Vivani looking to get slim with Cortigent neurostimulation spin
The Vivani Medical Inc. combination appears to be over less than three years since its inception after the company reported plans to spin off Cortigent, the division that develops brain implants.

Neuromod raises €10M to widen tinnitus device reach
Neuromod Devices Ltd. raised €10 million (US$10.9 million) in financing to expand the reach of Lenire, which treats tinnitus. The fundraise, which was an expansion of its series B financing round, was led by existing investors Fountain Healthcare Partners and Panakès Partners.

Vivani looking to get slim with Cortigent neurostimulation spin
The Vivani Medical Inc. combination appears to be over less than three years since its inception after the company reported plans to spin off Cortigent, the division that develops brain implants.
Neuromod raises €10M to widen tinnitus device reach
Neuromod Devices Ltd. raised €10 million (US$10.9 million) in financing to expand the reach of Lenire, which treats tinnitus. The fundraise, which was an expansion of its series B financing round, was led by existing investors Fountain Healthcare Partners and Panakès Partners.
US NIH grant peer review to get a bit of a makeover
Looking to shave $65 million from its annual expenditures while streamlining the first stage of its two-level grant review process, the U.S. NIH is proposing to centralize the peer review of all applications for grants, cooperative agreements and R&D contracts within its Center for Scientific Review.
ISO, IEC advise against simplistic approaches to pulse ox performance
The U.S. FDA’s latest draft guidance on pulse oximeters drew comment from the International Standards Organization and the International Electrotechnical Commission, which are making the case that in addition to differences in pigmentation, the pulsatility of the tissue in contact with the device is also a factor in device performance.
CMS eyes ventilation coverage for beneficiaries with COPD
Medicare beneficiaries in the U.S. diagnosed with chronic obstructive pulmonary disease (COPD) may soon be covered for positive pressure ventilation in the home per a draft coverage memo from CMS.
Today's news in brief
BioWorld MedTech briefs for March 12, 2025

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Digital health

New AI fall prediction tool being rolled out across the NHS
Regulatory
The U.K.’s national health service (NHS) is rolling out a new artificial intelligence (AI)-powered tool which can predict a patient’s risk of falling with a 97% accuracy rate. The AI software designed by Cera Care Ltd. is already in use in more than two-thirds of NHS integrated care systems across...
Aspargo Companion can spray most meds, alert to missed doses
Drug design, drug delivery and technologies
In an advance that could significantly lighten the load for caretakers in the “sandwich generation” and reduce loneliness in elderly patients, Aspargo Labs Inc. developed a metered delivery device that optimizes absorption of pharmaceuticals and reminds users to take their medications.
Novelty of PCCP filings a source of drag for FDA, industry
Regulatory
Nick Decker, directory of global regulatory policy for Roch Holding AG’s Roche Diagnostics division, said the FDA is moving carefully into the PCCP space, and industry, too, is taking a measured approach in adopting the PCCP concept.
Little interest shown in premarket use of MDSAP audits
Regulatory
A number of regulatory agencies have signed on to the Medical Device Single Audit Program (MDSAP) for postmarket uses, but the U.S, FDA cannot use these audits for premarket purposes.

Financings

Med-tech sector starts strong, with $6.28B in 2025 financings
Analysis and data insight
Med-tech companies raised $3.52 billion in 65 deals in February 2025, up from $2.76 billion across 56 transactions in January.

Newco news

Astellas-Yaskawa JV to build robot-based cell production platform
Deals and M&A
Astellas Pharma Inc. is setting up a joint venture with Yaskawa Electric Corp. to develop a new cell production platform using Yaskawa’s dual-arm humanoid robot called Maholo.

EEG earpiece predicts seizures up to an hour before onset
Neurology/psychiatric
The first patenting from Theta Neurotech Inc. sees the company’s co-founders describe their development of a wearable earpiece that uses an electroencephalography technology and machine learning algorithms to alert epilepsy patients 30 to 60 minutes before they have a seizure.
Dongkook Life Science secures ₩18B IPO
Financings
Dongkook Life Science Co. Ltd. (DKLS) priced a ₩18 billion (US$12.5 million) IPO on the Korea Exchange as South Korea’s first med-tech listing of the year.

Deals and M&A

Repligen buying 908 Devices’ Bioprocess Analytics portfolio
Diagnostics
Repligen Corp. acquired 908 Devices Inc.’s desktop portfolio of four devices for bioprocessing process analytical technology (PAT) applications for $70 million in cash.
Ajax, Boston Sci partner to develop new heart failure treatment
Cardiovascular
Ajax Health LLC, with backing from the $4 billion KKR Health Care Strategic Growth Fund II, and Boston Scientific Corp. launched a new business, Flowmod, to advance a system for treating heart failure developed by Boston Sci.
Boston Scientific to acquire Sonivie for up to $600M
Merger
Boston Scientific Corp. agreed to acquire Sonivie Ltd., developer of a therapeutic intravascular ultrasound system for denervation to treat resistant hypertension, pulmonary hypertension and chronic obstructive pulmonary disease. On a 100% basis, the deal is valued at $600 million with $400 million...
Teleflex buying Biotronik’s vascular intervention unit for $791M
Cardiovascular
In a flurry of news releases on Feb. 27, Teleflex Inc. reported plans to buy the vascular intervention business of Biotronik SE & Co. for €760 million (US$791 million), said it intended to split into two separate public companies, floated a $300 million accelerated share repurchase program and...
Solventum sells $4.1B purification unit to Thermo Fisher
U.S.
The trend of corporate pruning in med tech continues with Solventum Corp.’s decision to sell its purification and filtration business to Thermo Fisher Scientific Inc. for $4.1 billion. The announcement follows two other big company splits already in 2025: Baxter International Inc.’s separation of...

Europe

SCAAR data Prevails for Medtronic paclitaxel-coated balloon
Clinical
Medtronic plc reported results from a registry highlighting the effectiveness of the Prevail paclitaxel-coated balloon. The findings from the Swedish Coronary Angiography and Angioplasty Registry (SCAAR) were presented by Sacharias von Koch of the department of cardiology and clinical sciences at...

Asia-Pacific

Philips, Compumedics partnership expands sleep solutions
Respiratory
To increase diagnosis across Australia, the partnership will see Compumedics Ltd. of Melbourne supply its Somfit devices and electrodes to Philips’ pharmacy-based sleep programs in pharmacies across Australia.

FDA accepts Telix BLA for kidney cancer imaging agent
Regulatory
After a second round, the U.S. FDA has accepted for review radiopharmaceutical company Telix Pharmaceuticals Ltd.’s BLA for its kidney cancer PET imaging agent, TLX250-CDx (Zircaix, 89Zr-DFO-girentuximab), granting it a priority review with a PDUFA date of Aug. 27, 2025.
Kyorin drafts deals for chronic cough DTx, loss of smell therapy
Deals and M&A
Kyorin Pharmaceutical Co. Ltd. struck two licensing deals recently, including one with Hyfe Inc. Feb. 25 to develop the world’s potential first prescription digital therapeutic for chronic cough in Japan.

Clinical

Raft of FDA job cuts may slow med-tech approvals
Regulatory
In response to the news of reported layoffs at the U.S. FDA over the weekend, Advanced Medical Association president and CEO Scott Whitaker said in press release that these “significant job cuts could have a very negative impact on patient care in...
Spinal cord stimulation system shows significant pain relief
Neurology/psychiatric
Biotronik Neuro’s Prospera spinal cord stimulation system achieved more than 50% pain reduction for 86% of patients with back pain and 89% of patients with leg pain over two years, according to new study results.
Newronika gets IDE from the FDA for adaptive DBS trial
Regulatory
Newronika SpA's AlphaDBS recently secured an investigational device exemption from the U.S. FDA allowing it to begin a pivotal trial to evaluate the safety and efficacy of its adaptive deep brain stimulation system in patients with movement...
Heartflow CT scan predicts cardiac events 7 years out
Cardiovascular
A 1,000-person study using Heartflow Inc. technology demonstrated that findings of coronary plaque on heart CT scans could indicate which patients were at risk of cardiovascular events up to seven years in the future – potentially providing a road...
ITM marks a milestone in radiotherapeutic tumor therapy
Cancer
With positive results from a phase III study, ITM Isotope Technologies Munich SE said it has reached a landmark. The clinical trial of ITM-11, a synthetic, targeted radiotherapeutic agent for treating inoperable, progressive grade 1 or grade 2...
Bioprinting technique mimics heart tissue development
Cardiovascular
A new bioprinting platform to create tissues that can change shape as a result of forces generated by the cells, similar to what happens naturally during organ development, was developed by researchers from the University of Galway, Ireland.

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