Regulation
In this week’s Digital Health Roundup, Medtech Insight’s Ryan Nelson highlights Click Therapeutics’ FDA-cleared digital therapeutics (DTx) for depression and Sinaptica Therapeutics’ personalized neuromodulation for Alzheimer’s patients. Marion Webb discusses her interview with MindMaze’s John Krakauer on their gaming-focused DTx to help people recover from serious brain injuries. Elizabeth Orr introduces new voting members of the new Digital Health Advisory Committee and Natasha Barrow discusses Hello Heart’s new symptom-tracking feature in their heart-focused app.
This week, Establishment Labs Holdings announced the FDA gave it premarket approval for Motiva breast implant, Cologuard lands FDA approval for Cologuard Plus and GE HealthCare gets FDA nod for a new imaging agent. The FDA announces another expansion for TAP into ophthalmology and radiology. The AAMI and CTA will join forces to develop standards for AI and ML-enabled health care products.
Children with biliary atresia (BA) exhibited neurodevelopmental deficits and increased autism traits, with earlier surgery linked to better general neurodevelopment.
Stay current on regulatory guidelines from around the world with Medtech Insight's Guidance Tracker. Over 40 documents have been posted on the tracker since its last update.
This week, the FDA announced a new head of its device evaluation office; synthetic genomics firm Constructive Bio landed $58m in funding; and Natera got a permanent injuction against NeoGenomics Labs' RaDaR assay.
This week, Neuralink announced it received US FDA breakthrough device designation for a device to restore sight; medtechs Discure and DeepLook secured new funding; FDA pump recalls from B. Braun Medical and Fresenius Kabi; Axonics prevails in patent infringement lawsuit with Medtronic; Merit Medical buys Cook Medical for $210m.
Click Therapeutics reports positive Phase 3 clinical data for CT-132, a digital therapeutic intended as an adjunctive treatment of episodic migraine. The company is pursuing FDA clearance and actively exploring opportunities to offer a drug-digital combination therapy with added clinical benefit that provides “a single, integrated experience for the patient, prescriber and payer.”
This week, two device testing labs in China landed FDA warning letters; refunds for 1Health.io clients; FDA AR/VR product list expands.
This week, a Delaware court awarded Auris Health shareholders $1bn in a lawsuit against Johnson & Johnson; Abbott recalled some FreeStyle Libre 3 sensors; and McKesson purchased a controlling interest in a Florida cancer care chain.
Stay current on regulatory guidelines from around the world with Medtech Insight's Guidance Tracker. Nearly 80 documents have been posted on the tracker since its last update.
Vitestro's automated blood drawing robot received CE marking on August 28. The company is limiting release of the robot over the next 12 months to a small number of selected hospitals, with plans to scale up production thereafter.
Medtech Insight interviewed Meri Beckwith, co-founder of “anti-CRO” clinical research organization Lindus Health, about his company’s efforts to make clinical trials more efficient and reliable.
The Food and Drug Administration’s final guidance outlines the agency’s thinking for sponsors submitting de novo requests electronically, which they must starting in October 2025.
This week, a medical group sued the FDA to block a lab-developed test rule; the FDA published guidance on device classifications; Defibtec issued a recall of its chest compression device and ICU Medical updated instructions for its infusion pump batteries; Maui Imaging raised a $4m DOD grant to put imaging tech into military-based trauma units.
When a medtech regulatory consultant receives some 500 requests in a single month on LinkedIn for a guide he has spent 300 hours writing, you know it is a critical topic.
The US FDA has published draft guidance for predetermined change control plans for medical devices along with recommendations for sponsors including them in marketing submissions to the agency.
Former FDA device center head Jeffrey Shuren is facing conflict of interest claims for not recusing himself from regulatory decisions involving clients of his wife’s legal firm. Critics call for an investigation and stricter ethics compliance.
A government report requested by US lawmakers Debbie Dingell and Anna Eshoo to review the FDA’s postmarket surveillance of medical devices stresses that strengthening the system is critical to addressing adverse events linked to devices after they hit the market.