Insightec gains FDA approval for Exablate Neuro use in Parkinson’s
Insightec Ltd. received U.S. FDA approval for use of its Exablate Neuro device to address severe motor symptoms in patients with Parkinson’s disease, offering a new option for patients who have not found adequate relief from medications. Exablate Neuro uses focused ultrasound to create lesions in the brain without requiring an incision or implant.

Iancu: Patent reform undone by multinationals’ apathy over IP rights
Patent reform in the U.S. revolves largely around the subject matter eligibility question, but Congress is reluctant to intervene – a predicament addressed recently by Andrei Iancu, formerly the director of the U.S. Patent and Trademark Office.

Insightec gains FDA approval for Exablate Neuro use in Parkinson’s
Insightec Ltd. received U.S. FDA approval for use of its Exablate Neuro device to address severe motor symptoms in patients with Parkinson’s disease, offering a new option for patients who have not found adequate relief from medications. Exablate Neuro uses focused ultrasound to create lesions in the brain without requiring an incision or implant.
Iancu: Patent reform undone by multinationals’ apathy over IP rights
Patent reform in the U.S. revolves largely around the subject matter eligibility question, but Congress is reluctant to intervene – a predicament addressed recently by Andrei Iancu, formerly the director of the U.S. Patent and Trademark Office.
Glucomodicum reports positive data from its needle-free CGM
Glucomodicum Oy reported positive results from a clinical study in which its needle-free continuous glucose monitor, Talisman, was tested in participants across both standard multi-hour glucose tolerance and ambulatory conditions involving exercise and meals.
CMS formally proposes to terminate ESRD choices program
The U.S. Centers for Medicare & Medicaid Services indicated it will act on a previous proposal to terminate the Treatment Choices Model for ESRD at the end of the current calendar year because of a failure of the program to deliver on the promised efficiencies and improvement in outcomes.
UK industry encourages renewal of rare disease framework
Representatives of patients’ groups, industry bodies and venture philanthropy funders are calling for a renewal of the U.K. Rare Diseases Framework, to put fresh momentum behind translational research and clinical trials, streamline regulatory oversight and improve access to therapies.
More than $16B in med-tech funding raised through 1H25
The med-tech sector raised $16.46 billion in the first half of 2025, an 18% increase over the $13.94 billion raised during the same period in 2024.
Today's news in brief
BioWorld MedTech briefs for July 8, 2025.

BioWorld Insider Podcast

Robert Williamson, CEO of Triumvira Immunologics, and Hernan Bazan, CEO of South Rampart Pharma, discuss bracing for tariffs, NIH grant cuts and gifting China a biopharma leadership position.

Listen now

Digital health

Lunit, Microsoft to codevelop cloud-based clinical AI solutions
Deals and M&A
Lunit Inc. reported a new collaboration with Microsoft Corp. July 2 to jointly develop medical AI programs accessible on Microsoft’s Azure cloud platform.
MHRA tackles risk classification for digital mental health tech
Regulatory
The U.K. Medicines and Healthcare Products Regulator Agency dropped a guidance for digital mental health technologies that clarifies several key points, such as when the DMHT qualifies as software as a medical device.
Reset Moves to promote well-being in children with neurodivergence
Neurology/psychiatric
Focused on promoting well-being amongst children with neurodivergence, Reset Moves Pty Ltd. created app-based games to help children not only focus with greater clarity, but also to better help them re-engage in certain settings.
Hinge Health rings NYSE bell as IPO raises $437M
Orthopedics
Hinge Health Inc.’s flexibility produced big rewards as the digital therapy company for physical rehabilitation finally began trading on the NYSE under the symbol HNGE on May 22 after delaying its IPO twice. Hinge co-founders Daniel Perez and Gabriel Mecklenburg rang the opening bell for the stock...

Financings

Kardium beats expectations with $250M haul
Cardiovascular
Kardium Inc. raised C$340 million (US$250 million) in an oversubscribed financing round to support commercialization of its Globe pulsed field ablation system for atrial fibrillation. Notably, the financing included an equity investment by an unnamed leading strategic investor. Kardium could...

Newco news

Alphadesign: AI creating proteins from scratch
Science
The Alphafold machine learning system for predicting a protein’s structure from its amino acid sequence has been adapted to make it possible to design de novo proteins that fold in a particular way and bind to prespecified target proteins. The sister system, called Alphadesign, works by generating...

Zip Diagnostics develops first rapid POC test for scabies
Infection
Zip Diagnostics Pty Ltd., Menzies School of Health Research and Axxin Pty Ltd., a Melbourne, Australia-based diagnostic instrumentation manufacturer, partnered to develop a rapid diagnostic test for scabies, a skin parasite that affects more than 200 million people each year.
Wearoptimo’s hydration sensor outperforms gold standard tests
Clinical
Health care technology company Wearoptimo Ltd. developed a next-generation microwearable sensor that accurately detects hydration levels, outperforming the needle-based gold standard.

Deals and M&A

Med-tech IPOs gain steam going into Q3
IPO
The IPO market for med-tech companies continues to set new records. With one IPO closed the last week of June, two slated for the first week of July and another pending, 2025 will shortly exceed the total number of IPOs closed in the previous two years combined as well as the number completed in 2022.
Two new options presented at ADA for early diagnosis of T1D
American Diabetes Association
Classically, the diagnosis of type 1 diabetes comes after a patient presents with unexplained weight loss, extreme thirst and frequent urination and a lab test reveals off-the-charts blood glucose levels. At the 85th Scientific Sessions of the American Diabetes Association in Chicago, researchers...
Illumina buying Somalogic for up to $425M to boost multiomics assets
Acquisition
In a bid to boost its multiomics holdings, Illumina Inc. reported an agreement to buy proteomics technology company Somalogic Inc. from Standard Biotools Inc. for $350 million in cash, plus up to $75 million in near-term performance-based milestones and performance-based royalties.
Caris settles IPO at $21, trading starts at $28
Cancer
Despite raising the price of its IPO twice, Caris Life Sciences Inc. left money on the table with a 33% increase in price as soon as trading commenced on the Nasdaq, though no one is squawking about raising nearly $500 million. The cancer diagnostics company initially priced its IPO at $16 to $18,...
23andme founder-led group outbids Regeneron for company
Acquisition
The 23andme Holding Co.’s saga came full circle with founder Anne Wojcicki regaining control of the bankrupt genetic testing company in a bidding battle against Regeneron Pharmaceuticals Inc.

Europe

Accunea’s Renosure device can save kidneys from being discarded
Clinical
Accunea Ltd.’s bioanalysis technology, Renosure, can measure creatinine clearance in machine perfused kidneys, according to data presented at the recent European Society of Organ Transplantation 2025.

Asia-Pacific

Multiple multianalyte sensors for diabetes on horizon
American Diabetes Association
Abbott Laboratories grabbed attention in early June with its announcement of a partnership with Tandem Diabetes Care Inc. to develop a multianalyte sensor for people with diabetes that would measure ketones as well as glucose.

MFDS clears world’s first ECG-based AI kidney disease software
Regulatory
South Korea’s Ministry of Food and Drug Safety on June 9 approved Vuno Inc’s AI-based Med-DeepECG Kidney software as a non-invasive method to screen for kidney dysfunction.
European Commission clamps down on Chinese med tech
Europe
The trade wars spanning the globe lined up some unlikely-seeming adversaries, and such is the case in the trade scrum between the EU and China.

Clinical

In-patient BYOD still troublesome for CGM makers
American Diabetes Association
With a growing number of people wearing continuous glucose monitors and an ever-shrinking number of hospital-based nurses, bringing your own device or using personal CGMs to measure glucose levels during hospitalizations seems like a no-brainer.
UK Women to be offered home-testing kits for cervical screening
Cancer
The U.K. government will offer women home-testing kits for cervical screening as part of an effort to tackle barriers and get more of them taking this potentially life-saving test.
AID system improves glycemic control in pregnancy
Diabetes
Pregnant women with type 1 diabetes who used a hybrid closed loop automated insulin delivery system averaged more than three additional hours per day in their recommended glucose range than those who managed their diabetes with insulin injections...
Fractyl pursues dual track to cure T2 diabetes
American Diabetes Association
At the American Diabetes Association 85th Scientific Sessions in Chicago June 20-23, Fractyl Health Inc. presented results from two studies evaluating very different approaches to treating – and possibly curing – type 2 diabetes.
Fineheart pursues FIH study of Flowmaker fully implanted heart pump
Cardiovascular
Fineheart SA will soon begin a first-in-human study of Flowmaker, its fully implantable left ventricular assist device, in France, after receiving authorization from the French National Agency for the Safety of Medicines and Health Products to...
Newel Health secures CE mark under MDR for BP app
Europe
Newel Health srl received CE mark certification under the European Medical Device Regulation for Amicomed, its digital therapeutic solution for hypertension management. The app, which was cleared as a class IIa medical device, provides clinical...

podcast microphone, sound waves on purple background Breakthrough medicines, billion-dollar deals, spectacular clinical successes and crushing failures all play a part in biopharma’s dynamic story. Developers make scientific advancements with the potential to change everything, only to face regulatory conundrums and ever-fluctuating markets. BioWorld tracks key events in the fast-moving sector every business day. Now, the BioWorld Insider podcast lets you hear directly from the movers and shakers whose collective work is changing how we all live. Join us each week for a new conversation.

Recent episodes:

View all

BioWorld

The news source of record covering the development of innovative human therapies for 25+ years

BioWorld MedTech

Actionable and timely intelligence on advances in medical devices and technologies for 20+ years

BioWorld Asia

A weekly monitor of biopharmaceutical news from the industry’s fastest-growing region

BioWorld Science

Essential discovery and preclinical research news to support crucial drug R&D decisions at the earliest stages

BioWorld Premium

Enjoy extended coverage for the most complete market view with BioWorld, BioWorld MedTech, and BioWorld Asia in a single, easy to access subscription

BioWorld MedTech

Today's news in brief

BioWorld

BioWorld MedTech

BioWorld Asia

BioWorld Science

BioWorld Premium