Masimo names med-tech vet Katie Szyman CEO
Masimo Corp. selected Catherine (Katie) Szyman, an industry leader with deep med-tech roots, to guide the company as it seeks to rebuild its reputation and revenues following a gritty two-year battle for control. Current CEO Michelle Brennan will serve as chairman of the Masimo board. Brennan stepped up to lead Masimo after founder and former CEO Joe Kiani resigned following a shareholder vote that ousted him from his position of board chair as part of a protracted proxy battle between Kiani and Politan Capital Management LP.

Roche receives FDA approval for STI point-of-care tests
Roche AG secured U.S. FDA 510(k) clearance for its cobas liat sexually transmitted infection (STI) multiplex assay panels. The tests, which also received a Clinical Laboratory Improvement Amendments waiver, will enable clinicians to detect several STIs including chlamydia, gonorrhea and Mycoplasma genitalium, in as little as 20 minutes.

Masimo names med-tech vet Katie Szyman CEO
Masimo Corp. selected Catherine (Katie) Szyman, an industry leader with deep med-tech roots, to guide the company as it seeks to rebuild its reputation and revenues following a gritty two-year battle for control. Current CEO Michelle Brennan will serve as chairman of the Masimo board. Brennan stepped up to lead Masimo after founder and former CEO Joe Kiani resigned following a shareholder vote that ousted him from his position of board chair as part of a protracted proxy battle between Kiani and Politan Capital Management LP.
Roche receives FDA approval for STI point-of-care tests
Roche AG secured U.S. FDA 510(k) clearance for its cobas liat sexually transmitted infection (STI) multiplex assay panels. The tests, which also received a Clinical Laboratory Improvement Amendments waiver, will enable clinicians to detect several STIs including chlamydia, gonorrhea and Mycoplasma genitalium, in as little as 20 minutes.
Ravgen aces Federal Circuit patent hearing against Labcorp
Ravgen Inc. prevailed in a hearing at the Federal Circuit over Labcorp Inc., seemingly bringing a close to a long-running dispute over patents for non-invasive prenatal tests. Ravgen has won damages that will likely exceed $400 million over alleged infringement of its patents for these tests, proof once again that a solid understanding of prior art is essential to avoid costly litigation.
LVIS launches Neuromatch Access in US, Korea as EEG diagnostic
Standing for live visualization of brain circuits, LVIS Corp launched the cloud-based Neuromatch Access platform as a software as a service to help neurologists and medical professionals review, interpret and analyze electroencephalogram (EEG) data.
EU eyes expansion of liability for AI in medical uses
Device makers know all too well the hazards of liability where their products are concerned, but those liabilities may soon balloon dramatically in the EU. Two pieces of EU legislation are in development, including the AI Liability Directive, which may have the effect of forcing the defendant in a liability case to prove that its product was not the cause of the alleged harm.
Today's news in brief
BioWorld MedTech briefs for January 22, 2025

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Digital health

Glooko, Hedia launch bolus dosing support solution
Diabetes
Glooko Inc. and Hedia ApS launched an integrated software solution in the U.K. to support people with diabetes who require advanced doses of bolus insulin. The solution combines Glooko’s diabetes monitoring platform with Hedia’s diabetes dosing recommendation app to deliver personalized insulin...
Brain DTx med-tech Brainaurora raises $75M with Hong Kong IPO
Financings
Brainaurora Medical Technology Ltd. debuted on the Hong Kong stock exchange Jan. 8 with a HK$583.18 million (US$74.93 million) IPO, offering about 181.11 million shares at HK$3.22 per share.
HHS floats much more stringent set of HIPAA security measures
Regulatory
Makers of digital health apps are not often subject to the provisions of the Health Insurance Portability and Accountability Act (HIPAA), but any such liabilities may soon become more onerous. The Department of Health and Human Services released a draft update for HIPAA cybersecurity mandates – the...
Strong growth predicted for APAC med-tech market in 2025
Regulatory
The Asia Pacific med-tech market is projected to reach $140 billion in 2025 in value, growing roughly 5% per year, driven largely by a rising demand for advanced and personalized medical technologies, including telemedicine and precision medicine.

Financings

Owlstone Medical raises $27M for Breath Biopsy platform
Cancer
Owlstone Medical Ltd. recently secured $27 million in the first close of its series E financing round for clinical trials and product commercialization based on its Breath Biopsy platform technology. The fundraise was led by Ventura Capital, joined by Aviva Ventures, Horizons Ventures and other...

Newco news

China’s NMPA clears country’s first mesenchymal stem cell therapy
Regulatory
China’s health regulator gave conditional approval to Platinum Life Excellence Biotech Co. Ltd.’s amimestrocel injection (hUC-MSC PLEB-001, Ruibosheng) as the nation’s first human umbilical cord-derived mesenchymal stem cell therapy to treat steroid-refractory acute graft-vs.-host disease on Jan....

Syncell raises $15M series A for precise spatial proteomics tech
Financings
Taipei, Taiwan- and Watertown, Mass.-based Syncell recently raised $15 million in series A financing to advance its subcellular protein purification and spatial proteomics analysis product called Microscoop Mint, based on its Microscoop platform technology.
Renerve raises AU$7M in Australian IPO for nerve repair
Regulatory
After raising AU$7 million (US$4.5 million) in is initial public offering on the Australian Securities Exchange last week, Renerve Ltd. is already exploring mainland China for its portfolio of nerve repair and regeneration products.

Deals and M&A

Quanterix merging with Akoya to bolster biomarker portfolio
Diagnostics
Quanterix Corp. plans to merge with Akoya Biosciences Inc., in an all-stock transaction that both companies hope will bolster their fortunes. The transaction will create an integrated solution for ultra-sensitive detection of blood- and tissue-based protein biomarkers.
Med-tech deals December 2024
Analysis and data insight
Med-tech deal values dropped sharply in December to $78.74 million, down from $424.5 million in November. For the full year, deal values reached $2.12 billion, representing a significant decline of 80% from 2023’s $10.63 billion and marking the lowest annual total in recent years
Boston Sci secures IVL tech with up to $664M Bolt buy
Medical devices
In early validation of widespread predictions of a robust year for M&A activity, Boston Scientific Corp. signed a definitive agreement to acquire the 74% of Bolt Medical Inc. it doesn’t already own for $443 million up front and up to $221 million in contingent milestone payments.
Stryker strikes early in 2025 with nearly $5B deal for Inari
Cardiovascular
With more than 60 acquisitions completed in the last decade, Stryker Corp. shows little fear in committing to offers that allow it to obtain the companies and technologies that have driven its impressive growth in stock price – up from $92 in Jan. 2015 to $356.70 in Jan. 2025. Still, the definitive...
Med-tech deal volume rises despite decline in total value in Q1 to Q3
Analysis and data insight
Med-tech deals activity dropped significantly in 2024, falling 84% from $9.83 billion in the first nine months of 2023 to $1.6 billion in the same period this year. While down from $6.59 billion in Q1 to Q3 2022, value is higher than $979.84 million in the comparable period in 2021.

Europe

New mixed-reality tool created to transform burn care
Dermatologic
The U.K.’s Buckinghamshire NHS Trust has partnered medical technology design experts from Team Consulting Ltd. to create a tool that can transform burn care treatment. The concept training tool incorporates mixed reality which maps ‘custom digital burns’ onto a mannequin to enable surgeons to...

Asia-Pacific

Incheon team mints new diagnostic test tailored to ‘twindemics’
Infection
Researchers have developed a novel point of care (POC) diagnostic that can test for multiple respiratory viral infections simultaneously, including for the flu and COVID-19. The POC diagnostic tool leverages a novel, non-enzymatic signal amplification method, according to study lead Eunjung Kim,...

Proteomics develops test that distinguishes endometriosis stages
Women's health
Women with endometriosis may soon be able to have a simple blood test to diagnose their disease thanks to a breakthrough by Proteomics International Ltd. that has developed a plasma protein biomarker panel that identifies all stages of endometriosis.
Competition ticks up to reset the clock for sepsis
Financings
When every hour’s delay in treatment increases the risk of death 8%, dialing down time to diagnosis takes on acute urgency for clinicians and regulators. When the disease being treated kills 20% of the global population and 33% of hospitalized patients in the U.S., the market opportunity attracts...

Clinical

Xeltis completes enrollment in EU pivotal trial for vascular access conduit
Regulatory
Xeltis BV completed enrollment in the EU pivotal trial for its restorative vascular access conduit, Axess. The prospective study will investigate the patency, safety and performance of Axess in adult patients with end-stage renal disease requiring...
AI helps UK doctors identify patients at risk of afib
Cardiovascular
An artificial intelligence-based tool developed by researchers in the U.K. is helping doctors identify people at risk of developing atrial fibrillation. Data from the ongoing Find-AF pilot study shows that the algorithm can comb through patients’...
FDA wary of overreporting of clinical study protocol deviations
Regulatory
The U.S. FDA’s draft guidance for reporting of deviations from clinical study protocols lends some insight as to the definition of a deviation, but the agency highlights some concerns about related compliance activities.
Merit unwraps Wrapsody endoprosthesis PMA for the holidays
Regulatory
Merit Medical Systems Inc. received an early holiday gift this year, reporting that its Wrapsody cell-impermeable endoprosthesis has received premarket approval from the U.S. FDA and plans to begin commercialization of the device there in 2025.
Edap’s Focal One HIFU technology non-inferior to radical prostatectomy
Cancer
Edap TMS SA recently published data showing that its Focal One high intensity focused ultrasound technology is non-inferior to radical prostatectomy as a first-line treatment for localized prostate cancer. The company is also working towards...
Edwards bullish on TAVR, long-term growth at investor day
Deals and M&A
At its investor day conference, Edwards Lifesciences Corp. prognosticated that an expanded indication in transcatheter aortic valve replacement and rapid growth in its newer mitral and tricuspid heart valve technologies will accelerate total...

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