Medical technology

Endospan’s FDA nod for Nexus brings acquisition by Artivion closer

Thu, 09 Apr 2026 12:00:00 -0400

Endospan Ltd. Secured U.S. premarket approval for its Nexus aortic arch stent graft, bringing the company closer to being acquired by Artivion Inc. Under the terms of an existing agreement, Artivion has an option to acquire Endospan at any time within 90 days of the FDA approval.

FDA issues Medline with warning letter over Namic syringes

Thu, 09 Apr 2026 12:00:00 -0400

The U.S. FDA issued a warning letter to Medline Inc. having identified several issues with its Namic brand angiographic control syringes and manifolds used for the intra-arterial or intravenous administration of radiographic contrast media. The agency warned the company that failure to promptly address the violations identified in the letter may result in regulatory action being initiated, including seizure, injunction and civil money penalties.

Smart contact lens delivers adaptative glaucoma therapy

Thu, 09 Apr 2026 09:00:00 -0400

A smart polymer contact lens measures intraocular pressure (IOP) in real time and automatically releases medication into the eye when IOP goes beyond a critical limit. This technological advance, developed by scientists at the Terasaki Institute for Biomedical Innovation (TIBI), could enable personalized glaucoma therapy, avoiding poor patient adherence to their prescribed regimen and eliminating the need for bulky electronic devices. Animal models tolerate it well and, although the load is concentrated at the edges of the lens, it is still unknown how it could affect visual acuity.

UK formalizes zero tariffs deal with US, will pay more for drugs

Wed, 08 Apr 2026 12:00:00 -0400

The U.S. confirmed the agreement in principle made last December to exempt U.K. pharmaceuticals from import tariffs, as the U.K government put its commitment to spend more on patented drugs into effect.

Smart contact lens delivers adaptative glaucoma therapy

Wed, 08 Apr 2026 12:00:00 -0400

J&J introduces Varipulse Pro to Europe after CE mark

Wed, 08 Apr 2026 12:00:00 -0400

Johnson & Johnson launched its latest pulsed field ablation (PFA) catheter, Varipulse Pro, in Europe following CE mark approval, bringing another option to electrophysiologists looking to adopt PFA technology. The system features a new pulse sequence with a lower temperature profile and enables ablation that is five times faster than the previous sequence, while achieving equivalent lesions. It represents another significant development in the rapidly evolving PFA market that has transformed cardiac ablation treatment.

VC activity drives March med-tech financings to $2.4B

Tue, 07 Apr 2026 12:00:00 -0400

Total med-tech financings reached $8.54 billion in the first quarter (Q1) of 2026, reflecting a modest pullback from $9.33 billion in the same period of 2025 but remaining well above previous years. The Q1 2026 total exceeds the $6.45 billion recorded in Q1 2024 and $4.69 billion in Q1 2023, signaling continued recovery from the post-2021 downturn.

Kennedy sidestepping court order sidelining ACIP?

Tue, 07 Apr 2026 12:00:00 -0400

Don’t like a court order? Sidestep it. That seems to be the idea behind U.S. Health and Human Services Secretary Robert Kennedy’s latest changes to his renewal of the charter for the CDC’s Advisory Committee on Immunization Practices (ACIP).

Blockbuster deals push med-tech M&A above $40B in Q1 2026

Thu, 02 Apr 2026 12:00:00 -0400

Med-tech deal value, excluding M&As, totaled $628.41 million in the first quarter (Q1) of 2026, an increase of about 322% from the $149.08 million recorded in Q1 2025 though a 36% drop from Q4 2025‘s $978.58 million.

Molecular probe targeting PRMT5 enables pan-cancer PET-CT imaging

Thu, 02 Apr 2026 09:00:00 -0400

In a publication in Molecular Pharmaceutics, researchers from Fudan University Shanghai Cancer Center China present the design and construction of a positron emission tomography-computed tomography (PET-CT) molecular imaging probe that accurately targets PRMT5, enabling real-time dynamic visualization and quantitative detection of PRMT5 expression levels.

Med-tech players join efforts to tackle UK PAD amputations

Wed, 01 Apr 2026 12:00:00 -0400

With cases of peripheral artery disease (PAD) rising across the U.K., and lower limb amputations continuing to increase, med-tech companies joined forces with parliamentarians and health care professionals to push for urgent reform of the vascular sector.

US FDA looks to advance use of DHTs in drug trials

Wed, 01 Apr 2026 12:00:00 -0400

Seeking to increase their understanding of the opportunities and challenges of using digital health technologies (DHTs) in drug trials, the U.S. FDA’s CBER and CDER are requesting public feedback to help inform new guidance as the technologies continue to advance.

Lilly taps Insilico AI in $2.75B deal to expand pipeline options

Tue, 31 Mar 2026 12:00:00 -0400

Eli Lilly and Co. is deepening its investment in artificial intelligence-driven drug discovery through a multibillion-dollar expansion of its collaboration with Hong-Kong listed Insilico Medicine Inc. in a move that could broaden its reach into next-generation metabolic therapies. Under the deal terms, Insilico is eligible to receive $115 million up front, plus development, regulatory, and commercial milestone payments worth $2.75 billion, in addition to sales-based royalties. In exchange, Lilly gains exclusive global rights to develop and commercialize multiple candidates generated using Insilico’s AI platform, including preclinical oral therapies.

Whoop secures $575M, with Abbott a strategic investor

Tue, 31 Mar 2026 12:00:00 -0400

Whoop Inc. secured $575 million in a series G funding round at a $10.1 billion valuation to advance its AI-powered wearable platform for personalized and preventive health care. Abbott Laboratories joined the round as a strategic investor, backing the company’s push to expand access to its device amid growing demand.

Supreme Court shuts the door to three life sciences petitions

Tue, 31 Mar 2026 11:00:00 -0400

What do a patent dispute over a CRISPR/Cas system, a rejected whistleblower case involving lab tests and a vaccine injury claim parading as multidistrict tort litigation have in common? All three were denied cert in the U.S. Supreme Court’s latest orders list.

Lilly taps Insilico AI in $2.75B deal to expand pipeline options

Mon, 30 Mar 2026 12:00:00 -0400

Boston Sci boasts Champion-AF data but strokes signal a concern

Mon, 30 Mar 2026 12:00:00 -0400

Boston Scientific Corp. revealed much-anticipated data from the Champion-AF trial which showed that its Watchman FLX device provides superior protection from bleeding compared to non-vitamin K antagonist oral anticoagulants (NOACs) in patients with atrial fibrillation (AF). The left atrial appendage closure device also proved noninferior to NOACs in reducing stroke, cardiovascular death, or systemic embolism.

United’s Tyvaso nails endpoints in second phase III IPF trial

Mon, 30 Mar 2026 12:00:00 -0400

United Therapeutics Corp. is eyeing a possible priority review in its anticipated supplemental NDA for Tyvaso (treprostinil) in idiopathic pulmonary fibrosis (IPF) after the second phase III trial hit its endpoints, even besting the impressive findings from the first phase III study reported last year, and positioning United for a substantial commercial launch in 2027.

FDA should do more to protect adcoms from conflicts, GAO says

Fri, 27 Mar 2026 12:00:00 -0400

With all the focus of late on the U.S. CDC’s Advisory Committee on Immunization Practices (ACIP), the FDA’s 30-plus advisory committees have been flying under the radar, especially since many of them haven’t met for a few years now.

Xcath sees Iris robotic platform transforming stroke treatment

Fri, 27 Mar 2026 12:00:00 -0400

As robotic-assisted surgery platforms increasingly demonstrate that they can perform telesurgery safely, the question now is how soon remote operations will become part of routine clinical care. Eduardo Fonseca, CEO of Xcath Robotics Inc., reckons that within a decade the company’s Iris Surgical Robotic System could be in widespread use.

Medtronic cuts earnings guidance on Minimed factors

Thu, 26 Mar 2026 12:00:00 -0400

Medtronic plc has lowered its fiscal year 2026 earnings per share (EPS) guidance by 12 cents on the back of factors relating to its diabetes subsidiary, Minimed Group Inc., which recently completed its IPO.

Endogenex raises $50M for endoscopic diabetes treatment system

Thu, 26 Mar 2026 12:00:00 -0400

Endogenex Inc. has raised $50 million in an extension to its series C financing round to fund the completion of its pivotal Recet clinical study, which is evaluating the use of the company’s non-thermal pulsed electric field system for remodeling the duodenal tissue in adults with type 2 diabetes. The new capital will also be used to support the company's regulatory pathway toward U.S. FDA approval.

FDA reclassifies skin lesion diagnostic devices

Wed, 25 Mar 2026 12:00:00 -0400

The U.S. FDA has issued a final order to reclassify optical diagnostic devices for melanoma detection and electrical impedance spectrometers from class III to class II, with special controls required.

How to grow a startup in the AI era: MedTech Spotlight Korea 2026

Tue, 24 Mar 2026 12:00:00 -0400

AI and advanced biotechnology are reshaping South Korea’s med-tech sector, but great technology alone is not enough to build a successful medical device company, speakers said at MedTech Innovator’s Medtech Spotlight: New Impact Korea 2026.

Wait almost over, as SBIR nears reauthorization

Tue, 24 Mar 2026 12:00:00 -0400

A five-year reauthorization of the U.S. Small Business Innovation Research (SBIR) and Small Business Technology Transfer programs is just the president’s signature, or a few days, away.

CMR works with Nvidia to transform surgical robotics platforms

Tue, 24 Mar 2026 12:00:00 -0400

CMR Surgical Ltd.’s participation in Nvidia’s Physical AI health care robotics initiative is expected to accelerate the development of the next generation of intelligent surgical robotic systems powered by data, simulation and AI. As demand for minimally invasive procedures grows, more companies are entering the surgical robotics space.

With improved technologies, biomarkers, failed drugs may come into their own

Tue, 24 Mar 2026 12:00:00 -0400

At BioEurope Spring 2026, pharma representatives and investors shared their thoughts about current and future landscapes of different disease areas, and on how to move toward success – both at the level of individual companies and for indications as a whole.

Insitro and Bristol Myers Squibb expand ALS collaboration

Tue, 24 Mar 2026 09:00:00 -0400

Insitro Inc. has expanded its strategic collaboration with Bristol Myers Squibb Co. to advance a broadened portfolio of therapeutic programs for amyotrophic lateral sclerosis (ALS).

US Supreme Court says no to Takeda class action challenge

Mon, 23 Mar 2026 12:00:00 -0400

Crushing the hopes of drug and device companies, the U.S. Supreme Court’s March 23 orders list showed it denied cert in Takeda Pharmaceutical v. Painters & Allied Trades, which sought to rein in the expansion of class action lawsuits.

NICE issues guidance to improve kidney cancer care

Mon, 23 Mar 2026 12:00:00 -0400

With incidence of kidney cancer rising in the U.K., the National Institute for Health and Care Excellence (NICE) published its first comprehensive guidelines for diagnosing and treating the disease.