Gynecology & Urology

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.

The US FDA has granted marketing authorization to NOWDiagnostics for the first at-home over-the-counter test to detect syphilis, which the government says is on the rise.

This week, the US FDA sent a warning letter to maker of batteries for AEDs, AMCO; Virtual Incision successfully completed the first hysterectomy its miniaturized robotic-assisted surgery device MIRA; The DOJ finalized a rule that requires government-operated health care facilities to provide accessible equipment for people with disabilities; the FDA compiled its resources on reprocessed medical devices onto a new web page; and more.

GE HealthCare announced it will team up with AWS to build new generative AI models and applications that can help doctors find key patient information faster and help with diagnosing and treating patients.

CMR Surgical has launched a multicenter pediatric clinical trial for its Versius surgical robot system across three UK sites. The trial will enroll 150 children for urological procedures, with patient outcomes followed for up to a year post-surgery.

The Milan-based drugmaker, which is reportedly attracting attention from private equity firms, has put in a strong performance in the first half of the year, helped by a strong showing for its rare disease franchises.

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.

The Phase III study success is good news, but not the surprise upside that Bayer needs to lift investor sentiment.

A Trump-aligned think tank doesn’t have too much to say about the US FDA – which is probably a good thing for the agency. But it does reinforce the reality that abortion politics will continue to impact the agency – and that ties to industry may be a bipartisan area of concern.

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.

Breathomics, UTI diagnosis and advanced wound healing innovations were among the center stage technologies at BioWales in London 2024. Hear from CEO John McKinley on Imspex Diagnostics' plans in embedded podcast.  

The unanimous decision that the Alliance for Hippocratic Medicine lacks standing to challenge the FDA’s relaxation of the abortion pill REMS leaves unclear whether the court would have deferred to the agency’s expertise on the merits. 

The unanimous decision that the Alliance for Hippocratic Medicine lacks standing to challenge the FDA’s relaxation of the abortion pill REMS leaves unclear whether the court would have deferred to the agency’s expertise on the merits. 

The unanimous decision that the Alliance for Hippocratic Medicine lacks standing to challenge the FDA’s relaxation of the abortion pill REMS leaves unclear whether the court would have deferred to the agency’s expertise on the merits.

UK-based Amber Therapeutics said it raised $100m in a series A financing round led by New Enterprise Associates. It plans to use the proceeds to fund the development of Amber-UI through pilot and pivotal studies aiming US regulatory approval.

2024 In Vivo Rising Leader Somer Baburek wants to overhaul how endometriosis is diagnosed and managed with a product that she says has billion-dollar potential.    

An investigator, an investor and an inventor walk into the New York Stock Exchange, and it’s no joke. Women’s health is a fruitful investment with a clear path to financial return. 

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.

17-OHPC medicines are to be pulled from the market in Europe due to a potential link with cancer and the lack of efficacy data. The move comes around a year after the US regulator withdrew its approval of a similar drug from Covis.

Phase III results suggest Bayer’s elinzanetant has a safety and efficacy advantage over its Astellas rival in reducing hot flashes, but investors are still not convinced the drug will be a blockbuster.