Beta Bionics Inc. kicked off the new year with plans for an initial public offering of 7.5 million shares “as soon as practicable.” Expected to be priced at $14 to $16 per share, the IPO would gross $105 million to $120 million for the insulin delivery device maker.
With key officials yet to be confirmed at the U.S. Department of Health and Human Services, the acting secretary imposed an immediate pause throughout the department on publicly issuing any document or communication without first getting it approved by a presidential appointee.
Beta Bionics Inc. kicked off the new year with plans for an initial public offering of 7.5 million shares “as soon as practicable.” Expected to be priced at $14 to $16 per share, the IPO would gross $105 million to $120 million for the insulin delivery device maker.
With key officials yet to be confirmed at the U.S. Department of Health and Human Services, the acting secretary imposed an immediate pause throughout the department on publicly issuing any document or communication without first getting it approved by a presidential appointee.
In a boon for companies developing brain-computer interface (BCI) technologies, researchers have used a BCI and artificial intelligence to restore touch sensations in a bionic arm.
The backlog of requests for Medicare national coverage analyses is a matter of record, but a new analysis highlights how deep that backlog runs. CMS declared it will review a petition from Impulse Dynamics to consider coverage of cardiac contractility modulation, responding to a request the company filed more than two and a half years ago.
Med-tech stocks experienced a turbulent year of ups and downs in 2024, as the BioWorld Med-Tech Stock Index saw lows of almost 15% and gains of nearly 5% before closing the year up 0.21%. This modest rebound follows consecutive declines of 4.44% in 2023 and a steep drop of 39.58% in 2022.
The BioWorld Insider podcast is a monthly dive into the business and science of drug development. Conversations with CEOs and BioWorld analysts in the past 12 months have included a wide range of chats with experts who are shaping the future.
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...
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.
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...
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.
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...
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.
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....
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.
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 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
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.
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 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.
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...
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,...
Beijing’s policy of favoring domestic medical technology is a matter of record, but the European Commission apparently heard enough from EU med tech firms to take action. The Commission posted notice that it may take steps to retaliate by restricting bids from China for EU government contracts in...
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.
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...
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’...
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 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.
A new method to diagnose skin cancer was validated for the first time in clinical trials that show Dermr Health Solutions Pty Ltd.’s non-invasive microneedle patch collects near-equivalent genetic information compared to a skin biopsy without pain...
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...
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.