Respiratory

The director of the US FDA’s device center is sounding the alarm on the scarcity of critical devices for pediatric patients and says the agency is focused on solutions to this “unique” challenge.

In this first of a two-part series from CES, Medtech Insight tunes into two companies that developed AI-powered cameras to detect respiratory diseases and chronic diseases respectively, two companies offering at-home testing for cholesterol, and a saliva test to help detect symptoms of perimenopause.

In this week’s Digital Health Roundup, Medtech Insight’s Marion Webb brings highlights from Deloitte’s 2025 Life Sciences Outlook Report with medtech leaders’ forecasting significant investments in AI/GenAI. Brian Bossetta talks about the US FDA’s newly formed Digital Health Advisory Committee. Elizabeth Orr highlights the pros and cons of penetration testing for cybersecurity and talks about the US FDA’s final guidance on pre-determined change control plans. Natasha Barrow highlights UK MHRA's AI Airlock Pilot program and MANIFEST.

This week, HistoSonics announced it will bring its ultrasound system for destroying liver tumors into VA hospitals, Edwards Lifesciences reports encouraging TRISCEND II trial results at TCT, study finds blood test for CRC screening are less cost-effective than alternatives, and more.

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.  

Philips has issued a recall of various Trilogy ventilators due to safety issues that may affect their ability to properly function. The US FDA has designated the recall class I, its most serious.

Philip Morris described a scenario of being essentially blacklisted by the health care sector and its CDMO partners as it threw in the towel on its £1.1bn acquisition of UK inhalation specialist Vectura. It agreed to offload the firm at a fraction of the initial cost.

According to Zacks Equity Research, the new trial seeks to support AlphaVac’s adoption in the European market, where pulmonary embolism prevalence and severity is an estimated 435,000 events annually.

Smiths Medical has recalled scores of Bivona tracheostomy tubes due to a manufacturing defect that can result in disastrous consequences. The company reports multiple injuries, and one death, linked to the devices.

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.

The US Food and Drug Administration released six warning letters and two close-outs last month, including four warnings to marketers of unauthorized continuous positive airway pressure (CPAP) cleaners or sanitizers.

The devices include a digital therapeutic to treat ADHD and a tongue muscle stimulator to prevent sleep apnea and snoring. They all initially reached market via the de novo process and have now been declared class II.

Elevated levels of the COVID-19 virus in wastewater samples have prompted the Biden-Harris administration to dust off its free testing program in preparation for the fall and winter. The US Postal Service will begin shipping the testing kits in September.

Inari Medical is updating use instructions for a clot-removing catheter due to the potential for serious adverse effects, including death.

Philips has filed a lawsuit against a Pennsylvania lab it hired to analyze sound abatement foam that prompted widespread recalls of its CPAP machines. Philips alleges PSN Labs grossly overestimated the risk to patients, which led Philips to initiate a larger recall than it otherwise would have.

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.

This week, Roche filed suit against Foresight Diagnostics and Stanford University over patent infringement; the former head of a COVID-19 test company was convicted of securities fraud; and Baxter announced a recall of Life2000 ventilators.

Last month, the US FDA increased the number of injuries and deaths initially reported in a March recall from Philips, which the company disputed. The FDA now says its adjusted numbers were in error.

The US Federal Trade Commission wants to clean up the FDA’s Orange Book by purging medical device patents that the commission says should not be in the listing. The FTC argues improper patents in the Orange Book block lower-cost generic equivalents from coming to market. Medtech Insight spoke to attorney Sara Koblitz about the FTC’s delisting push.

The US FDA is reporting dozens more additional deaths associated with a May recall of Philips ventilators than initially reported. The company says it stands by its original number of seven and has reached out to the FDA.