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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.  

Spain has one of the highest incarceration rates in Europe, with 160 individuals imprisoned per 100,000 residents. In 2020, 43,494 people were incarcerated in facilities not managed by regional health authorities — essentially all regions except Catalonia, the Basque Country, and Navarra.

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 released six more device classifications in early September, including products from Edwards, Interscope, and Baxter Healthcare.

Edwards Lifesciences’ Critical Care business “invented the hemodynamic monitoring category, and its solutions are currently used in more than 10,000 hospitals globally to better understand the cardiovascular condition in real-time for critically ill patients, which helps improve outcomes,” says BD, which sees synergies and new innovation opportunities across the groups’ data sets and platforms. Acquired for $4.2bn cash, Critical Care generated more than $900m in revenue in 2023.

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.

Getinge says it plans to pay about $477m for organ transport and services company Paragonix Technologies in an effort to “redefine the market standard in transplantation.”

Moximed aims to accelerate adoption of its MISHA Knee System, De Novo-approved by the US FDA in April 2023, with $91m in Series D funding. Chris Gleason, president and chief executive officer, offers perspective on the company’s innovative technology and commercial growth activities.

Announced in conjunction with a $97m Series D financing round, Neptune underscores its gastrointestinal focus and robotics aspirations by spinning out Jupiter Endovascular, which will leverage $21m of the funding to support ongoing development of its Endoportal Control technology.

Following FDA clearance of its Edison Histotripsy System in October 2023 for the non-invasive destruction of liver tumors using focused ultrasound, HistoSonics announces plans for $102m in new funding led by Alpha Wave Ventures. “Bubbles have never been so powerful,” the company says.

The nonprofit XLerator Network has announced eight life sciences start-ups, including five medtech concerns, that will benefit from its educational support and other resources. The NIH-funded program is designed to build entrepreneurial skills and promote commercialization of academic technologies in the US Southeast region. 

MindMaze seeks to create a beautiful immersive experience for patients recovering from brain injuries. Chief medical director John Krakauer, clearly a “Star Wars” fan, discusses the significant need for digital therapeutics at a time when therapists are in short supply, as well as the challenges facing the DTx space as a whole.

This week, Medtronic recalled a nerve monitoring system due to reports of false responses. The US FDA approved the first auto-injector for opioid-overdose, made by Purdue Pharma. The agency granted de novo authorization for Labcorp’s PGDx elio plasma focus Dx used by labs for genetic profiling. As of 7 August, 950 AI/ML devices have been approved by the FDA. EKO Health teamed up with LSU to help detect arrhythmias and murmurs in student-athletes.

Medtronic and Abbott announced partnership to integrate Abbott’s CGM sensor with Medtronic’s insulin pump, which marks a major departure from Medtronic’s former “closed-system” approach. Medtronic also announced FDA clearance of its Simplera CGM, paving the way for its use in smartpens.

In an interview with Medtech Insight, Matt Bettonville, investor at cancer-focused venture firm Yosemite, discussed its criteria for evaluating potential investments in oncology and his outlook on the future oncology landscape.

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.

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.     

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.

AI and generative AI ruled much of the discussion at HLTH Europe 2024. A panel of health care leaders from Microsoft, Philips, insitro and Johnson & Johnson discussed how these new technologies are already transforming health care and pointed to risks and challenges.