Medtech Insight is part of Pharma Intelligence UK Limited

This site is operated by Pharma Intelligence UK Limited, a company registered in England and Wales with company number 13787459 whose registered office is 5 Howick Place, London SW1P 1WG. The Pharma Intelligence group is owned by Caerus Topco S.à r.l. and all copyright resides with the group.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By

UsernamePublicRestriction

Approvals

Set Alert for Approvals

Digital Health Roundup: Brain Talk On Seizures, Alzheimer's, Stress, Anxiety; Medtronic's OR Report; Health Care AI; UK Guidances

In this month’s Digital Health Roundup, Medtech Insight’s Marion Webb highlights AI discussions at the HLTH Europe conference and an interview with Motif Neurotech's CEO Jacob Robinson. Elizabeth Orr discusses DeepWell DTx's newly launched VR game for treating stress-related hypertension and anxiety. Natasha Barrow provides an overview of Digital Mental Health Technologies regulation in the UK and Brian Bossetta reports ‘the good and bad’ from Medtronic's report on digital technologies' use in the operating room. 

Digital Health Roundup Digital Health

News We’re Watching: Nipro Medical Invests $397.8M In First US Facility; Baxter, Hamilton Ventilator Recalls; FDA Warnings; And More

This week, Nipro Medical Corp. announced it will invest $397.8m to build a US-based production plant, generating 232 new jobs; both Baxter and Hamilton announced ventilator recalls; Imperative Care wins FDA clearance for its stroke catheter; Intelligent Ultrasound Group plc entered into a conditional sale and purchase deal to sell its Clinical AI business to GE HealthCare for £40.5m; RMI distributed 350m rapid test kits in the fight against HIV/AIDS; Jiangsu Shenli Medical Production Co., Ltd received a second FDA warning letter about quality and safety of plastic syringes.

News We're Watching Approvals

News We’re Watching: FDA Issues Monkeypox EUAs, IMDRF Publishes AI Principes, Quest Buys LifeLabs

This week, the US FDA authorized EUAs for at-home mpox tests and announced a public workshop on implanted brain devices; the IMDRF published guiding principles on good machine learning practices for AI; and Quest announced its deal to acquire a Canadian diagnostic firm.

Regulation Commercial

Pediatric Orthopedic Device Drought Continues, Study Finds

A recent review of orthopedic device approvals between 2018 and 2022 found that less than 10% of 510(k) devices – and less than 5% of PMA and de novo products – have been authorized for use in children, highlighting the ongoing lack of pediatric devices. 

Regulation Pediatrics

News We’re Watching: DMCA Judicial Review Upheld; Abbott’s Rio CGM Available OTC; J&J’s Velys Wins FDA UKA Expansion

This week, AdvaMed and MITA win appeal to prevent repair companies from hacking medical devices, the FDA cleared Abbott’s Libre Rio CGM for OTC sales, J&J MedTech wins expanded clearance for Velys knee medical robot, the FDA updates its AI program, Canary Speech secures $13m in series A funding and Xeltis won FDA approval for an IDE submission to begin enrolling patients for a pivotal study for aXess.  

News We're Watching Approvals

News We’re Watching: Medtronic Recall, More Chinese Syringe Woes, Surgical Robot Clearance

This week, Medline announced recalls of tracheal tubes; Eko Health raised $41m in Series D funding; and the US FDA announced participation in collaborative communities focused on brain-computer interface devices and more.

Approvals FDA

Abbott’s Lingo Becomes Second FDA-Cleared OTC Blood Glucose Monitor

The FDA has given the green light to over-the-counter sales of Abbott’s Lingo blood glucose monitoring device, which is intended for use by healthy people who want to track the crucial biomarker.

Approvals FDA

Zeto Wins FDA Clearance For Novel Seizure Detection Device

The US FDA has granted 510(k) clearance to a California medical technology company for a brain monitoring device that detects seizures in patients with brain injury or trauma.

FDA Innovation

News We're Watching: ACLA Sues FDA; Philips Recall; New Funding In Women’s Health; FDA Nods

This week, the ACLA filed a lawsuit against the US FDA; Philips recalled around 100,000 ventilators; women’s health companies Natural Cycles and Gameto padded their coffers; and Canary Medical and J&J’s Ethicon received FDA nods.

News We're Watching Approvals

News We’re Watching: Panel Backs Guardant Shield, EU Adopts AI Act, Magellan Settles Lead Test Claims

This week, an FDA advisory panel recommended approval of the Guardant Shield blood test for colon and rectal cancers; the EU Council signed off on the world’s first AI law; and the FDA challenged innovators to develop AI/ML technologies to detect gait freezing in individuals with Parkinson’s disease

Regulation Commercial

EMA Answers More Questions For Manufacturers of Drug-Device Combos

Will it be necessary to provide a new medical device notified body opinion when changes are being made to the medicine in an integral drug-device combination product? This is just one of the new topics addressed in an updated Q&A document from the European Medicines Agency.

Europe Approvals

Notified Bodies Double Certifications Since 2022

A recent survey by trade group TEAM-NB found that the number of certificates issued under the IVDR and MDR doubled between 2022 and 2023. However, application completeness remained an issue, with notified bodies estimating that a third of applications were less than 25% complete.

Regulation Approvals

News We’re Watching: Telehealth Advances; AI Regulation; NIH Backs SIRT; Oura Upgraded

This week, a House subcommittee advanced a two-year telehealth extension, Chuck Schumer and a bipartisan group of senators introduced a plan for regulating AI, the FDA launched its new online RST Catalog, NIH recommends targeted radiotherapy cancer treatment, and Oura announced new health features for its smart ring.

News We're Watching Artificial Intelligence

FDA Grants De Novo Marketing Authorization For At-Home Retinal Imaging Device

Notal Vision, a Virginia-based patient-centric ophthalmic remote monitoring services provider, has won de novo marketing authorization from the US FDA for a product that allows patients to keep tabs on their age-related macular degeneration while at home.

FDA OTC Devices

US FDA Clearance For Masimo’s Stork Delivers OTC Baby Monitoring Tech Competition

Masimo receives US regulatory clearance for Stork OTC baby monitoring system six months after Owlet received first clearance for its Dream Sock following a regulatory stumble which halted sales of a previous device, Smart Sock, in 2021.

Approvals OTC Devices

US FDA Grants Teal Health’s At-Home Cervical Screening Device Breakthrough Device Designation

Teal Health reached a significant milestone in its mission to bring a prescription-based, at-home, self-collect cervical cancer screening device to market.

Women's Health FDA
See All
UsernamePublicRestriction

Register