Medical Devices

Vivani to spin off neurostimulation business

The independent company will trade as Cortigent and advance brain implants to he...

Proteomics announces Australian launch of predictive di...

Proteomics International Laboratories has launched the PromarkerD diabetic kidne...

EPA to reconsider emissions standards for medical devic...

 Last year, the EPA issued a final rule that would limit emissions of ethylene o...

J&J’s Monarch robot wins FDA nod for AI software update

Using Nvidia and GE Healthcare technology, the robotic surgery system is intende...

MicroTransponder receives $65m to advance stroke care w...

MicroTransponder has received $65m in Series F funds to enhance its stroke care ...

Hinge Health, a virtual physical therapy firm, files fo...

The digital health IPO market has slowed to a crawl in recent years, but experts...

Nearly a third of FDA medical device adverse event repo...

A study has found that nearly a third of medical device AEs were reported by man...

Renal denervation: An advanced procedure to relieve hyp...

The post Renal denervation: An advanced procedure to relieve hypertension appea...

FDA grants 510(k) clearance for J&J MedTech’s Monarch Q...

The FDA has granted 510(k) clearance for J&J MedTech’s Monarch Quest, which is d...

Vivani Medical to spin-off neurostim business Cortigent...

Cortigent will focus on neuromodulation devices while Vivani presses ahead with ...

Vantis Health completes €10m funding round to advance p...

Vantis Health has completed a €10m ($10.9m) Series A funding round led by Angeli...

FDA approves GT Metabolic Solutions’ 50mm magnet in Mag...

GT Metabolic Solutions' 50mm magnet of the MagDI System has received clearance f...

Labcorp to buy Opko unit’s cancer test assets for up to...

Labcorp will acquire the oncology diagnostics operations from BioReference Healt...

FDA accuses Mid-Link of copying or falsifying medical d...

FDA officials said the agency would reject all data from the Chinese service pro...

A 2,100% Markup: My Battle with a Vastly Overpriced Kne...

I asked if I could purchase the brace myself and bring it to the surgery. The an...

Former Magellan CEO pleads guilty in inaccurate lead te...

Magellan Diagnostics’ former CEO Amy Winslow has pleaded guilty to concealing ma...

Sooma gains FDA approval to commence study of tDCS device

Sooma Medical has received FDA approval, allowing the company to initiate a pivo...

Australia’s TGA approves Body Vision’s AI imaging system

Australia’s Therapeutic Goods Administration (TGA) has approved Body Vision Medi...

World Oral Health Day highlights need for good hygiene

Oral hygiene is driving the demand for restorative and preventative solutions in...

Analysts say Dexcom’s FDA warning unlikely to impact 20...

Dexcom was issued with an FDA warning letter after issues with “manufacturing pr...

Capstan brings surgical robot to valve replacement

Capstan Medical, a startup focused on robotic-assisted mitral and tricuspid valv...

FDA clears Caristo’s AI-powered CAD diagnostic software

The US Food and Drug Administration (FDA) has given the greenlight to Caristo Di...

Neuromod secures €10m to expand tinnitus treatment devi...

Neuromod Devices has secured €10m ($10.8m) in equity financing to broaden the re...

Douglas Kelly, deputy science director at FDA’s device ...

Kelly, who made several key hires at the CDRH and helped negotiate the last user...

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