Medical Device Newsletter


Fischer Medical launches in global healthcare with affordable MRI system made in India

Fischer Medical Ventures, based in Chennai, has pioneered the cost-effective, high-quality production of Magnetic Resonance Imaging (MRI) systems, making it the first c


Inspira Technologies’ cardiopulmonary bypass system, Inspira ART100 gets US FDA 510(k) clearance

Inspira Technologies OXY B.H.N. Ltd., a pioneering company in medical technology, has announced that it has received 510(k) class II clearance from the US Food and Drug


Abbott obtains CE mark for dual-chamber leadless pacemaker

Abbott has received a CE mark for its dual-chamber leadless pacemaker, enabling sales in Europe. The Aveir DR system, with synchronized pacemakers for the right atrium


Philips reports 7 deaths linked with BiPAP alarm problem

Philips Respironics has recalled certain BiPAP ventilators due to false alarm issues potentially causing shutdowns. Affected models include BiPAP A30, A40, and V30, alo


Avita obtains FDA approval for cell harvesting device Recell GO System

Avita Medical has received FDA approval for its next-generation autologous cell harvesting device, the Recell GO System, designed for burns and skin defects. This syste


Hologic recalls more than 53,000 radiographic markers associated with 71 injuries

Hologic has recalled over 53,000 radiographic markers linked to 71 reported injuries, as per the FDA. While the devices remain available, Hologic urges reporting any ad


MarinHealth Medical Center introduces cardiac MRI tool

MarinHealth Medical Center has expanded its cardiac care services by launching cardiac magnetic resonance imaging (MRI) technology through the Haynes Cardiovascular Ins


FDA declares OptumHealth’s infusion system recall as Class I

The FDA has issued a Class I recall for OptumHealth's infusion systems, the most severe classification, affecting 208 devices distributed in the US between August 2020


FDA approves InnoVoyce’s VYLO Laser System for medical use

InnoVoyce's VYLO Laser System has obtained 510(k) clearance from the US Food and Drug Administration (FDA). The VYLO Laser System, using a 455nm blue light laser, deliv


Route 92 catheter recall associated with 2 injuries, 1 death

Route 92 Medical has recalled about 1,000 catheters in the U.S. due to malfunctions linked to two patient injuries and one death, as per the FDA. Physicians use these c


FDA declares Vyaire’s twin tube recall as Class I

Vyaire Medical faces another FDA setback, this time regarding tubes in its cardiopulmonary exercise test (CPET) system, following a prior Class I recall this year. The


Teltonika’s TeltoHeart smart wristband gets CE MDR certification

Teltonika, a Lithuanian company, has obtained European CE MDR (Class IIa) certification for its TeltoHeart smart wristband, meeting medical device standards. This wrist


FX Shoulder gets FDA 510(k) clearance for glenoid baseplates

FX Shoulder Solutions has received FDA 510(k) clearance for its full-wedge augmented glenoid baseplates, adding six new options to its portfolio. This expands the total


BD obtains FDA approval for cervical cancer screening self-collection kit

BD has received FDA approval for a kit enabling self-collection of specimens for human papillomavirus (HPV) testing, allowing individuals to collect vaginal specimens i


J&J’s Megadyne discontinues pediatric electrode pad after burn reports

Johnson & Johnson's Megadyne business has ceased production of a pediatric electrode pad due to reports of patient burns during procedures. Initially part of a Dece


Boston Scientific : Recalls more than 1M angiographic catheters

Boston Scientific has globally recalled over 1 million angiographic catheters due to increased complaints about difficulties advancing the guidewire through the device&


ClearPoint Neuro gets US FDA 510(k) clearance for its Prism Bone Anchor Accessory

ClearPoint Neuro, Inc., a global leader in device and therapy enablement for brain and spine, has received 510(k) clearance for its Prism Bone Anchor Accessory, marking


Stereotaxis signs APT buyout to gain catheters for surgical robots

Stereotaxis, a surgical robot developer, is acquiring Access Point Technologies (APT) to bolster its capabilities in creating robotically steered diagnostic catheters f


Abbott recalls Heartmate pump following 70 injuries, 2 deaths reported

Abbott recalled the Heartmate 3 left ventricular assist system due to blood leakage or air entering device seals. The FDA noted 81 incidents, including 70 injuries and


US Medical Innovations’ ablation system gets FDA issues 510(k) clearance

The US Food and Drug Administration (FDA) has granted 510k clearance to US Medical Innovations for its Canady Helios Cold Plasma (CHCP) Ablation System, a novel technol


Outset Medical receives FDA nod for dialysis accessory months after halting sales

Outset Medical has obtained 510(k) clearance for TabloCart with prefiltration, an accessory designed to eliminate sediment and minerals from water prior to entering the


Masimo’s at-home baby monitor approved for use without prescription

Masimo has obtained FDA approval for its Stork baby monitor, enabling over-the-counter purchase without a prescription. This at-home system, utilizing pulse oximetry te


Medtronic gets approval to sell renal denervation device in China

Medtronic has secured the first approval for a renal denervation system from China’s National Medical Products Administration (NMPA). This approval allows Medtron


FDA approves CereVasc’s eShunt system study for hydrocephalus

The US Food and Drug Administration (FDA) has authorized investigational device exemption (IDE) for CereVasc to commence the STRIDE pivotal study, evaluating its eShunt


United Imaging gets FDA clearance for uMR Jupiter 5T MRI system

United Imaging, a manufacturer of medical imaging and radiotherapy equipment, has obtained clearance from the US Food and Drug Administration (FDA) for its uMR Jupiter


Optomed introduces AI fundus camera for instant diabetic retinopathy detection

Optomed USA launches Optomed Aurora AEYE, a handheld AI fundus camera for diabetic retinopathy's rapid detection beyond mild stages. Developed with AEYE Health, it faci


GE HealthCare introduces radiation therapy computed tomography solution

GE HealthCare has unveiled Revolution RT, a radiation therapy computed tomography (CT) solution aimed at enhancing imaging precision while simplifying the simulation wo


Senseonics obtains FDA clearance to pair CGM implant with insulin pumps

Senseonics announced it obtained an integrated continuous glucose monitoring (iCGM) designation from the FDA via the de novo pathway, enabling integration of its implan


BrioHealth obtains FDA nod to trial BrioVAD ventricular assist device

BrioHealth Solutions has received FDA approval for its BrioVAD system under an investigational device exemption (IDE). The company aims to assess the BrioVAD's efficacy


NeuroSmart Portable MER system paves way for improved treatments in Parkinson’s disease

The integration of brain pacemakers and the NeuroSmart Portable MER system marks a significant leap in Parkinson’s disease treatment, offering precise deep brain


Infutronix infusion pump recall associated with 6 injuries, 1 death

Healthcare professionals rely on Infutronix's Nimbus infusion pump systems, also marketed as Halo, for administering medications and fluids. These devices deliver liqui


Exo received FDA-clearance for AI tools and adds to handheld ultrasound system

Exo received FDA clearance for its Iris device in 2021 and expanded its capabilities in 2022. These clearances apply to handheld portable diagnostic ultrasound systems,


Abbott received FDA approval for Esprit resorbable scaffold

Abbott's Esprit resorbable scaffold system gained FDA approval for treating blocked arteries below the knee (BTK). While angioplasty is favored over vein bypass surgery


Fresenius Medical Care recalls 2M dialysis devices due to toxin exposure risk

In 2022, the FDA alerted healthcare providers to potential toxin exposure from Fresenius Medical Care hemodialysis systems, involving non-dioxin-like (NDL) polychlorina


Medtronic received FDA approval for Inceptiv closed-loop spinal cord stimulator

Medtronic's Inceptiv closed-loop spinal cord stimulator (SCS) received FDA approval for chronic pain treatment, aiming to minimize overstimulation compared to open-loop


FDA approves Lumicell’s breast cancer imaging tool

Lumisystem comprises two integral components: Lumisight and Lumicell DVS. Lumisight is a molecular entity sensitive to enzymes predominantly present in and around 


Exactech recalls shoulder devices

In 2021, Exactech initiated a recall due to premature wear in hip replacement products, later identifying defective packaging lacking an essential oxygen barrier layer.


Scopio Labs obtains de novo nod for bone marrow analysis software

Founded in 2015, Scopio aimed to revolutionize microscopy and has since achieved significant milestones. These include obtaining CE marks and FDA clearances, raising $6


AtriCure launches cryoSPHERE+ probe for pain management

AtriCure has introduced the cryoSPHERE+ cryoablation probe to enhance post-operative pain management. This device, part of the cryoICE platform, received 510(K) clearan


Lumicell secures FDA approval for imaging platform

Lumicell has obtained FDA approval for its LUMISIGHT optical imaging agent (NDA) and Lumicell Direct Visualization System (DVS) (PMA). Together known as LumiSystem, the


GE HealthCare launches AI-enhanced ultrasound systems

GE Healthcare introduces Voluson Signature 20 and 18 ultrasound systems, integrating AI for women's health imaging. These systems aim to streamline exams and enhance di


Intuitive’s introduction of new da Vinci 5 robot steals Q1 spotlight

Intuitive Surgical saw strong growth in robot procedures and system placements in Q1, but the focus of the earnings call was on the launch plans for the da Vinci 5 plat


Simpson obtains FDA breakthrough device designation for Acolyte system

The Acolyte system assists in accurately placing guidewires and catheters within coronary vessels. Simpson Intervention's Acolyte Image Guided Crossing and Re-Entry Cat


FDA extends import alert to block all plastic syringes from Chinese manufacturer

The FDA enforces import alerts to enable the detention of products without physical examination, typically when a company is found to violate good manufacturing practic


MMI receives de novo nod for microsurgery robot

Medical Microinstruments (MMI) secured de novo authorization for its Symani Surgical System, assisting surgeons in reconnecting small blood vessels. The FDA cleared the


Kalogon launches custom wheelchair cushion Orbiter Med

Kalogon's Orbiter Med is a bespoke wheelchair cushion catering to individual seating needs. Approved by the Centers for Medicare & Medicaid Services (CMS) under HCP


Getinge received EU MDR certification for Advanta V12 stent

Getinge has obtained the European Union (EU) Medical Device Regulation (MDR) certificate for its Advanta V12-covered stent system, confirming compliance with EU standar


Smiths Medical recalls thousands of ventilators due to fault linked to 8 serious injuries

Healthcare professionals rely on gas-powered portable ventilators for oxygen administration in various settings, including during transportation and at accident scenes.


FDA grants de novo nod to AI tool for sepsis detection

Prenosis secured de novo clearance for a predictive tool assessing sepsis risk within 24 hours, featuring a prioritized list of influencing parameters. Sepsis, a severe


Eko wins FDA nod for AI to detect signs of heart failure using stethoscope

Eko Health received 510(k) clearance for a stethoscope feature detecting a heart failure indicator during routine exams. In primary care, echocardiography and other tra


Teleflex catheterization kit recall due to 10 injuries, 1 death

Teleflex is recalling about 335,000 catheterization kits in the U.S. following the Food and Drug Administration's announcement of an issue linked to 10 injuries and one


Baxter secures FDA clearance for delayed Novum IQ infusion pump

Baxter has secured 510(k) clearance for its large-volume infusion pump (LVP) Novum IQ after a three-year process with the FDA.



FDA re-issues ban on electric shock devices

In January, human rights groups urged the FDA and the Department of Health and Human Services to promptly release a proposed ban on electric shock devices, now that Con


Abbott receives a CE mark for the 6-year insertable cardiac monitor

Competition in insertable cardiac monitors (ICMs) has surged recently. Boston Scientific debuted Lux-Dx ICM's initial version in Europe in 2022 and gained U.S. clearanc


HCG designs a Patient App, to enable seamless access to doctors and medicines

HealthCare Global Enterprises Ltd., India's largest cancer care network, introduces the HCG Care app, a groundbreaking tool in oncology care. Developed in collaboration


IIT Madras designs customizable, indigenous electric standing wheelchairs: NeoStand

IIT Madras has unveiled NeoStand, India’s most adaptable electric standing wheelchair, catering to the needs of wheelchair users. NeoStand features a compact desi


Neuronetics received FDA clearance for the device to treat depression in adolescents

During an August earnings call, Neuronetics announced submitting a 510(k) application to expand Neurostar transcranial magnetic stimulation (TMS) device's eligible popu


J&J Medtech, Nvidia associate to bring AI to the operating room

Researchers advocate for AI integration in surgery to aid navigation, enhance surgical robots, and refine operations, with companies like Intuitive Surgical already imp


Deka’s automated insulin delivery system, powered by a patient-led app, acquires FDA clearance

Tidepool, a nonprofit born from grassroots efforts by diabetes patients, obtained 510(k) clearance for Tidepool Loop in early 2023, allowing users to pair preferred ins


Abiomed’s latest Impella recall related to 129 injuries, 49 death reports

Abiomed recalled its Impella pumps due to the risk of catheter rupture through the left ventricle wall, posing serious health risks, per the FDA. Over 66,000 devices di


Vyaire Medical recalls Airlife resuscitators over defect connected to 2 death reports

In January, Vyaire advised customers and distributors to discard Airlife manual resuscitators made in 2017 or earlier or lacking a manufacturing date. Though the fault


Aster MIMS Kozhikode collaborates with to implement an AI-powered stroke care solution

Aster MIMS Hospital in Kozhikode has partnered with, a provider of AI solutions for medical imaging, to enhance stroke care and diagnosis. This collaboration in


Fujifilm India inaugurates Open MRI machine in Hyderabad at Vijaya Diagnostic Centre

Fujifilm India has introduced its advanced Open MRI machine, "APERTO Lucent," at Vijaya Diagnostic Centre, India’s leading B2C diagnostic chain, enhancing access


Abbott recalls the Heartmate LVAD communication system

Abbott issued a recall for a communication system that monitors heart failure patients implanted with its Heartmate 3 left ventricular assist device (LVAD) because of t


Intuitive gets FDA clearance for new da Vinci robot

Intuitive Surgical has obtained 510(k) clearance from the Food and Drug Administration for its fifth-generation robotic surgery system, aimed at maintaining its leading


Volta Medical’s AF-Xplorer obtains a CE Mark as per European Medical Device Regulation MDR 2017/745

Volta Medical, a leading health tech company, has obtained CE Mark for its Volta AF-Xplorer under the new European Medical Device Regulation MDR 2017/745. This AI tool


Medtronic recalls more than 45,000 catheter tubing units following injury reports

Medtronic is recalling over 45,000 cerebrospinal fluid (CSF) drainage and sampling tubes in the U.S. due to issues linked to 26 injuries. The FDA categorized the recall


Royal Philips presents an AI-enabled CT 5300 system equipped with advanced capabilities

Royal Philips, a leader in healthcare technology, launches the Philips CT 5300 system with advanced AI capabilities for diagnostics, interventions, and screenings. This


US FDA marketing authorization for miniaturized robotic-assisted surgery device: Virtual Incision

Virtual Incision, a subsidiary of cultivate (MD), has received marketing authorization from the US FDA for the MIRA Surgical System (MIRA), marking a significant milest


Digital app improves speech in stroke patients: NIHR study

A recent NIHR-supported study highlights the effectiveness of iTalkBetter, a digital platform that improves speech for those with aphasia. Developed by the Neurotherape


Fujifilm India embarked on Echelon Synergy at CT & MRI User Conclave

Fujifilm India introduced the Echelon Synergy MRI Machine during its CT & MRI User event, focusing on the future of CT and MRI technologies. This system incorporate


Sanskritech introduces CDSCO-approved ultra-portable anytime health monitoring bag: Swandook

Sanskritech, an Indian health-tech company backed by Mylab, has launched Swandook, an innovative health monitoring bag approved by CDSCO. It's touted as the world's fir


MGI Tech, Eurofins Genomics associate to advance precision health with revolutionary DNBSEQ-T20×2 sequencer and affiliated technologies

MGI Tech, a leader in life science tools, has partnered with Eurofins Genomics Europe Genotyping A/S (Eurofins Genomics). Eurofins Genomics placed the first corporate o


Volta Medical’s AF-Xplorer obtains CE Mark as per European Medical Device Regulation MDR 2017/745

Volta Medical has obtained the CE Mark for its Volta AF-Xplorer under the new European Medical Device Regulation MDR 2017/745, allowing sales in the European Union. Thi


US FDA clearance to Zimmer Biomet’s ROSA Shoulder System for robotic-assisted shoulder replacement surgery

Zimmer Biomet Holdings, Inc., a global medical technology leader, has gained FDA clearance for its ROSA Shoulder System, marking it as the world's premier robotic surge


Fujifilm India creates its first installation with endoscopic ultrasound machine Aloka Arietta 850 at Fortis Hospital

Fujifilm India has installed its first Aloka Arietta 850 endoscopic ultrasound system (EUS) at Fortis Hospital, Bengaluru, aiming to enhance treatment for patients with


Philips’ high-powered & fast motorized mobile C-arm, Zenition 90 enables surgeons provide high-quality patient care

Philips has introduced the Image Guided Therapy Mobile C-arm System 9000 – Zenition 90 Motorized, enhancing surgical care accessibility. Tailored for intricate va


US FDA awards humanitarian device exemption approval to SeaStar Medical’s Selective Cytopheretic Device for paediatric acute kidney injury

SeaStar Medical Holding Corporation, a leader in medical technology, announces FDA approval of the Selective Cytopheretic Device (SCD) Paediatric (SCD-PED) under a Huma


Getinge bolsters commitment to Indian healthcare as it unveils Servo-c ventilator

Getinge, a global leader in medical technology, has introduced its cutting-edge Servo-c mechanical ventilator to the Indian market, catering to diverse respiratory need


MIVI seeks FDA approval for stroke catheter as trial fulfils primary endpoint

MIVI Neuroscience showcased encouraging results at the 2024 International Stroke Conference in Phoenix, Arizona, USA, in February. They have submitted data to the US Fo


Widex brings SmartRIC devices for natural hearing

Widex has launched the WidexSmartRIC hearing aid, aiming to improve natural hearing. Its unique L-shaped design optimizes microphone placement for better speech capture


Exactech and Statera collaborate to design smart reverse shoulder implants

Exactech, based in the US, collaborates with Canadian medical device developer Statera Medical to innovate the world’s first smart reverse shoulder implant. This


IntuiTap’s VerTouch device acquires US FDA approval

IntuiTap Medical has gained approval from the US Food and Drug Administration (FDA) for VerTouch, its handheld imaging tool. This FDA clearance confirms the device's sa


Philips blocks sale of sleep, respiratory devices in the US for FDA consent decree

Philips has agreed to cease selling new sleep therapy and respiratory care products in the U.S., following a significant recall launched about two-and-a-half years ago.


Metropolis collaborates with Singapore-based AI solutions provider ‘Qritive’ to revolutionize cancer detection

Metropolis Healthcare, India’s top diagnostic service provider, partners with Qritive, a global AI solutions leader for pathology labs, to bolster cancer diagnosi


Aster CMI Hospital’s neurology department devises AI Carpal Tunnel Syndrome to detect median nerve in ultrasound videos

Aster CMI Hospital emerges as a leading advocate for healthcare AI, pioneering innovative technology to support medical professionals in various treatment aspects. It i


StimLabs’ Corplex P, a human umbilical cord-derived medical device, receives US FDA 510(k) approval

StimLabs, founded in 2015 to advance regenerative medicine, announces FDA clearance of Corplex P, a groundbreaking medical device derived from human umbilical cord tiss


Edwards acquires FDA clearance for first transcatheter tricuspid valve replacement treatment.

Edwards Lifesciences has gained FDA approval for its Evoque tricuspid valve replacement system, marking a significant advancement as the first transcatheter treatment f


FDA receives additional reports of casualties linked to Philips’ recalled respiratory devices

The Food and Drug Administration (FDA) has observed a surge in medical device reports (MDRs) concerning Philips’ respiratory products, including instances of fata


Fresenius brings dialysis technology to the US with FDA approval

Fresenius Medical Care announced 510(k) clearance for its 5008X Hemodialysis System, a high-volume hemodiafiltration dialysis therapy device using diffusion and convect


Insulet acquires CE mark for integration of insulin pump with Abbott CGM

Insulet has secured a CE mark for integrating its Omnipod 5 insulin pump with Abbott’s Freestyle Libre 2 Plus continuous glucose monitor (CGM) sensor. This cleara


Hologic wins FDA approval for AI-enabled cervical cancer screening system

Hologic has gained regulatory approval to sell an AI-powered cervical cancer screening system in the U.S. Named the Genius Digital Diagnostics System, it digitizes Pap


Boston Scientific’s spinal cord stimulators endorsed for non-surgical back pain

Boston Scientific's Wavewriter spinal cord stimulator (SCS) systems have gained FDA approval for non-surgical back pain (NSBP) management. This expands the label to inc