In Vitro Diagnostics

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.

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.

When a medtech regulatory consultant receives some 500 requests in a single month on LinkedIn for a guide he has spent 300 hours writing, you know it is a critical topic.

At last, there is more transparency for medtech manufacturers about testing and certification costs. But BSI is still the only notified body to have published lead times under the medtech regulations.

Without new tools, cyber security risks related to the increasing digitization of healthcare will remain unmonitored and under-researched, a new report warns.  

Three $1bn+ alliances were penned in July. In the top alliance by deal value, Dren Bio teamed up with Novartis for the discovery and development of therapeutic bispecific antibodies for cancer using Dren Bio’s proprietary targeted myeloid engager and phagocytosis platform. The deal could be worth up to $3bn. The companies will collaborate to advance selected targeted myeloid engager programs in oncology through clinical candidate selection, at which point Novartis will assume full responsibility for all remaining development, manufacturing, regulatory and commercialization activities. In the top M&A, Eli Lilly penned a definitive agreement to acquire Morphic Therapeutic for $57 per share or approximately $3.2bn. Morphic's pipeline includes integrin therapies for autoimmune and fibrotic diseases and cancer and is led by Phase IIb candidate MORF-057. The selective oral small molecule inhibitor of α4β7 integrin is being evaluated for ulcerative colitis and Crohn's disease. It could provide Lilly with a strong competitor to Takeda Pharmaceuticals' marketed IBD therapy Entyvio (vedolizumab). Financing reached $4.6bn in biopharma, $769m in devices, and $373m in diagnostics.

The global leaders in imaging have set full-year sales growth outlooks of low to mid-single digits, with China market headwinds due to prevail throughout 2024. Pent-up China demand will be the upside from 2025, industry believes.

Harmonization through increased centralization was a key theme that ran through a recent discussion between Erik Vollebregt and Tom Melvin about the MDR. Both agreed that far-reaching short-term changes are not only possible but vital.

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.

Unilabs and C2N Diagnostics signed a multi-year agreement that will expand access to C2N’s Alzheimer’s tests in Europe and other countries.

During Q2, biopharma merger and acquisition deal value reached $22.2bn and drew in $36.3bn in potential deal value from alliances. Device company M&A values reached $21.3bn, while in vitro diagnostics and research tools players’ M&A activity totaled $631.6m.

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.

Many in the EU will be taking their traditional summer break in August. They will be leaving much in the political and regulatory melting pot as they go.

Having already voiced their commitment to working to resolve issues with the implementation of the MDR and IVDR, the national competent authorities for medical devices around the EU are now also calling for a longer-term view.

In June, the US Supreme Court reversed the Chevron doctrine, a long-standing precedent requiring courts to defer to regulatory agencies when statutory language was ambiguous. But will that decision prevent the FDA’s final rule on laboratory developed tests from taking effect? A legal expert weighs in.

Dr Peter Liese and Dr Vytenis Andriukaitis, both familiar names when it comes to the regulation of medical technology in the EU, have been elected as MEPs at a time when the EU’s medtech regulations are being targeted for urgent change.

In the EU, developers struggle to tell potential investors how many trials a device might require, the potential duration or associated costs. Tom Melvin explains how to tackle these issues in a third piece* based on a recent interview.

The US FDA has created a web page with answers to common questions concerning the agency’s final rule on regulating laboratory developed tests as medical devices.