Medical technology

Abbott receives CE mark for dual glucose, ketone sensing systems

Thu, 28 May 2026 12:00:00 -0400

Abbott Laboratories received CE mark approval for two dual glucose and ketone sensing systems, bringing to the market sensors that could be transformational to the lives of people with diabetes at risk of diabetic ketoacidosis.

Conexeu Sciences launches preclinical program for bioregenerative breast matrix

Thu, 28 May 2026 09:00:00 -0400

Conexeu Sciences Inc. has launched a preclinical development program for B.R.E.A.S.T. (Bio-Regenerative Ergonomically Architected Smart Tissue), its 3D-printed bioregenerative breast matrix, at the Wake Forest Institute for Regenerative Medicine (WFIRM), a leading regenerative medicine research organization.

Insulet initiates voluntary correction on Omnipod devices

Wed, 27 May 2026 12:00:00 -0400

Insulet Corp. has initiated a voluntary medical device correction affecting insulin pump pods in its Omnipod product lines after discovering a manufacturing issue that could lead to the leaking of insulin and the under-delivery of doses in some patients. The company said that some pods from specific lots may have a small tear in the cannula.

AI, remote care drive new models for Australian medtech

Tue, 26 May 2026 11:00:00 -0400

Artificial intelligence, remote monitoring and need-based innovation are beginning to reshape Australia’s medtech sector’s devices, as well as the way health care itself is delivered, according to speakers at the 2026 Ausmedtech conference in Perth May 19-20.

AI, remote care drive new models for Australian medtech

Thu, 21 May 2026 12:00:00 -0400

Sizing up an epidemic, with diagnostics and bioinformatics

Thu, 21 May 2026 10:00:00 -0400

It is not surprising that a large Ebola outbreak would be considered a public health emergency of international concern. But the current PHEIC is notable for the speed with which it was declared, speaking to the urgency of the situation. World Health Organization Director-General Tedros Adhanom Ghebreyesus declared the outbreak a PHEIC on Sunday, May 17, without first convening an emergency committee. That step is unprecedented.

As IVL technologies advance, Shockwave looks to defend its lead

Thu, 21 May 2026 08:00:00 -0400

As interests and competition in the intravascular lithotripsy (IVL) market heats up, Shockwave Medical Inc. said it believes that its latest coronary IVL catheter, the C2 Aero, and other projects in the pipeline, will help it to maintain its leadership in calcium modification.

US Fed Circuit clarifies standing in the face of licensures

Wed, 20 May 2026 12:00:00 -0400

The short story of the U.S. Court of Appeals for the Federal Circuit’s May 19 opinion in Recor Medical Inc. v. Medtronic Ireland is that the lower court got it wrong when it ruled Medtronic lacked the required standing to bring an infringement countersuit against Recor because it had granted an exclusive license for products covered by the two asserted patents. The case was reversed and remanded.

Subgroup analysis of the Champion-AF trial shows age not a factor

Wed, 20 May 2026 12:00:00 -0400

A subgroup analysis of data from Boston Scientific Corp.’s Champion-AF trial, which looked at the outcomes for patients with atrial fibrillation treated with a left atrial appendage closure (LAAC) device compared to direct oral anticoagulants (DOACs), found that the efficacy and safety of LAAC compared to DOAC are not affected by age. The data were presented at the EuroPCR conference in Paris.

Sizing up an epidemic, with diagnostics and bioinformatics

Wed, 20 May 2026 12:00:00 -0400

FDA approval advances personalized cancer diagnostics

Wed, 20 May 2026 12:00:00 -0400

The evolution of cancer diagnostics continues with the FDA’s May 20 approval of Guardant Health Inc.’s Guardant360 Liquid cDx. The new blood-based comprehensive genomic test assesses a 100-times wider genomic footprint than the previously approved Guardant360 cDx to deliver comprehensive tumor profiling results, according to the company. It noted that the seven companion diagnostic indications already approved for the older test will transfer to the new one.

All Women data show Allegra edge in female TAVR patients

Wed, 20 May 2026 12:00:00 -0400

Data from the All Women clinical trial, which looked at the Allegra transcatheter aortic valve replacement (TAVR) system compared to balloon-expandable valves (BEV) in women with aortic stenosis, showed that Allegra delivered lower mean gradients and less prosthesis-patient mismatch than BEVs. The data presented at the EuroPCR conference in Paris was the first randomized head-to-head comparison of different TAVR platforms conducted exclusively in women.

Medical devices evolving into intelligent, adaptive systems

Tue, 19 May 2026 12:00:00 -0400

The convergence of robotics, sensors and AI is reshaping how medical devices interact with patients, clinicians and healthcare systems. Across the field, from oncology to cardiology and women’s health, companies are integrating software, connectivity, data analytics and biological information into their products. And although traditional devices, such as screws for orthopedics or valves for cardiology, remain essential, the shift underway is leading to much more personalized medicine, which is more effective and safer, Eran Lerer, managing partner, at Shoni Health Ventures, told BioWorld.

Life sciences ‘sweet’ opportunity in US-China talks

Tue, 19 May 2026 12:00:00 -0400

Of all the issues that could be on the table at the talks between U.S. President Donald Trump and China President Xi Jinping, the life sciences sector is the “sweet spot” for collaboration between the two countries in a way that would benefit the world, Sen. Thom Tillis, R-N.C., said in a Brookings Institution webinar in advance of the two-day summit that starts May 14.

Elixir Dynamx system sees lower event rates than drug-eluting stent

Tue, 19 May 2026 12:00:00 -0400

Elixir Medical Corp. reported four-year data from the Bioadaptor randomized controlled trial presented at the EuroPCR conference in Paris, which showed that patients with coronary artery disease treated with its Dynamx coronary drug-eluting bioadaptor system experienced significantly lower event rates compared to those treated with Medtronic plc’s Resolute Onyx drug-eluting stent, including reduction in cardiovascular death.

Boston Scientific reports Seismiq IVL data from Fracture study

Tue, 19 May 2026 12:00:00 -0400

Boston Scientific Corp. reported positive results from the Fracture investigational device exemption trial which evaluated its Seismiq 4CE coronary intravascular lithotripsy (IVL) catheter in patients with severely calcified coronary artery disease. Late-breaking data presented at the EuroPCR conference in Paris showed that the pivotal study met its primary safety and effectiveness endpoints, with high rates of freedom from major adverse cardiac events at 30 days and strong procedural success.

Med-tech M&A’s blockbuster streak continues with $19B April value

Mon, 18 May 2026 12:00:00 -0400

Med-tech M&A value through the first four months of 2026 reached $62.01 billion, the highest total for the period since 2022’s $73.58 billion and a dramatic step up from 2025’s $20.03 billion and 2024’s $5.74 billion over the same period.

Boston Sci invests $1.5B in Mirus, gains option for TAVR system

Mon, 18 May 2026 12:00:00 -0400

Boston Scientific Corp. has invested $1.5 billion for a 34% equity stake in Mirus LLC in a deal under which it is also gaining an exclusive option to acquire the Siegel balloon expandable transcatheter aortic valve replacement (TAVR) system.

Sen. Cassidy’s primary loss increases uncertainty

Mon, 18 May 2026 12:00:00 -0400

On the heels of the ouster of Marty Makary as the U.S. FDA commissioner and the serial leadership vacancies at the CDC and the FDA’s drugs and biologics centers, the government’s adherence to science took another blow May 16 when Sen. Bill Cassidy, R-La., lost the Louisiana primary, ending his bid for re-election.

Sonomind raises €20M for ultrasound neuromodulation technology

Fri, 15 May 2026 12:00:00 -0400

Sonomind SAS raised €20 million (US$23 million) in a series A funding round for its ultrasound-based neuromodulation technology for depression. The funds will be used for clinical trials of the non-invasive device, which uses a custom-made acoustic lens to precisely target deep regions within the brain to bring relief to patients suffering from treatment-resistant depression.

Medical devices evolving into intelligent, adaptive systems

Thu, 14 May 2026 12:00:00 -0400

USPTO doubles down on inconsistencies in dual IPR-court action

Thu, 14 May 2026 12:00:00 -0400

The U.S. Patent and Trademark Office (USPTO) is driving home its message that inter partes reviews (IPRs) are not to be used in conjunction with court action presenting “inconsistent positions” as a litigation strategy.

Life sciences ‘sweet’ opportunity in US-China talks

Wed, 13 May 2026 12:00:00 -0400

Nvision secures $55 million, with backing from Abbott

Wed, 13 May 2026 12:00:00 -0400

Nvision Imaging Technologies GmbH raised $55 million in a series B financing round led by Abbott Laboratories for its quantum-enhanced sensing platform, Polaris, which uses quantum technology to boost the MRI signal of sugar-based imaging agents to enable real-time measurement of metabolism on standard MRI systems. Sella Brosh, CEO and co-founder of Nvision, told BioWorld that the funds are extremely important as the company is scaling the Polaris systems to many more sites worldwide, which is a capital intensive process.

Follow-ons hit 7-year high, lead med-tech's $10B start to 2026