Primary care doctors in England have been told by the National Institute for Health and Care Excellence (NICE) to prescribe a digital therapeutic instead of sleeping tablets for patients suffering with insomnia. Sleepio, an app developed by London-based Big Health Ltd. that uses an algorithm to provide personalized cognitive behavioral therapy (CBT), could benefit up to 800,000 people, according to NICE. It is recommending use of the app as an effective alternative to drugs such as zolpidem and zopiclone, after weighing evidence from 28 studies, including 12 randomized controlled trials. Read More
After listing on the Nasdaq market on May 18, Hong Kong-based diagnostics and genetic testing company Prenetics Group Ltd. saw its shares fall nearly 30% in early trading, dropping from $8.40 per share on listing to $5.70 by the end of trading May 19. Trading under the ticker PRE, Prenetics formed a merger with Artisan Acquisition Corp., a special purpose acquisition company, which was founded by entrepreneur Adrian Cheng. The transaction values Prenetics at an enterprise value of $1.25 billion, making the company the first Hong Kong unicorn to list on the Nasdaq. Read More
Following last week’s FDA approval of its Onyx Frontier drug eluting stent (DES), Medtronic plc released results at EuroPCR from a real-world, multicenter prospective study using its Resolute Onyx platform for percutaneous coronary interventions (PCI) in the left main artery. Rehovot, Israel-based Pi-Cardia Ltd. also released early data for patients treated with its Short Cut transcatheter device for coronary obstruction prevention. Read More
Sidekick Health AB expanded its partnership with Pfizer Inc., adding an atopic dermatitis offering to its integrated digital therapeutics solution. The app will roll out first in the U.K., followed by Belgium, Norway, Netherlands, Sweden, France, Ireland and Japan this year. Read More
Singapore’s Health Sciences Authority (HSA) recently updated its guidelines for software as medical devices (SaMDs) to broaden its scope on a number of related matters. The new guidelines were finalized after an industry input period when the HSA collected feedback until the middle of August 2021. It marks the second revision of HSA guidelines on SaMDs, the first revision was meted out in April 2020. Read More
Detecting the spread of cancer is a high priority for most health systems, but the U.K. National Health Service currently has a limited range of options when it comes to detecting breast metastases. That may change soon thanks to a review by the National Institute of Health and Care Excellence (NICE), which may endorse the use of the Sentimag system with Magtrace. Read More
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: ALR Technologies, Angle, Bracco, Cardionomic, Linamar, Lumiradx, Olympus. Read More
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Anika, Nanomix, Trinity Biotech. Read More
