Digital Health

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, 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.

Any apps, or indeed any software, which assist communication in the medical field need to be carefully evaluated against a tricky-to-comprehend rule in the EU’s Medical Device Regulation.

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.”

This week, surgical robot maker Globus Medical got a warning letter from the US Food and Drug Administration; the FDA cleared a hemostatic gel to stop blood loss; Medicare issued a payment code for Medtronic’s renal denervation device; and more.

Caresyntax said it will use the $180m it recently raised in a series C extension and debt financing round to build out its vendor-neutral surgery platform aimed to help surgeons with real-time and long-term decision support to improve patient outcomes and efficiencies.

Amulet announces $5.8 million in series A financing led by HealthX Ventures along with Incite Ventures, AllerFund, Mendota Venture Capital and Great Oaks Venture Capital. Allergy Amulet is for on-the-go testing of food to determine whether allergens are present.

A bipartisan bill now in the US Senate seeks to change the classification of implantable hearing aid devices to allow Medicare to reimburse for the devices, potentially expanding access for many Americans who require them.

Hello Heart has introduced a symptom tracking feature in its app, allowing users to log feelings of dizziness or shortness of breath in conjunction with blood pressure readings. The enhancement will help all users to monitor cardiovascular risks, but women in particular could benefit, the company suggests.

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.

 DHAC’s members, which span across multiple disciplines in the digital health industry, will hold their inaugural meeting this November.  

Big Health announced it received FDA clearance for its digital therapeutics for insomnia and hopes a new CMS fee schedule will pave the way to reimbursement.

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.

Together, Merck’s heads of oncology and head of digital health outline their cross-functional strategy to enhance care for cancer patients through digital tools.

A new AI lifecycle management framework from the US FDA’s Digital Health Center of Excellence introduces considerations for the seven steps of the AI lifecycle.

The implementation phase of the European Health Data Space is an opportunity to address “critical aspects” of the new regulation that require clarification, says pharmaceutical industry federation EFPIA.