Philips consent decree with FDA will halt sales of sleep apnea devices
Royal Philips NV agreed with the U.S. FDA to the terms of a consent decree focused on its Respironics business, following the recall of millions of its devices over the last few years. Although the details of the decree are being finalized, Philips said it will halt the sales of new continuous positive airway pressure (CPAP) and bilevel positive airway pressure (BiPAP) sleep therapy machines as well as other respiratory care devices in the U.S. until the conditions of the decree are met.

Philips consent decree with FDA will halt sales of sleep apnea devices
Royal Philips NV agreed with the U.S. FDA to the terms of a consent decree focused on its Respironics business, following the recall of millions of its devices over the last few years. Although the details of the decree are being finalized, Philips said it will halt the sales of new continuous positive airway pressure (CPAP) and bilevel positive airway pressure (BiPAP) sleep therapy machines as well as other respiratory care devices in the U.S. until the conditions of the decree are met.
$27M brightens treatment resistant depression outlook
Despite the approval of dozens of antidepression medications, an estimated 30% of individuals who experience major depressive disorder (MDD) fail to respond to treatment despite repeated trials. As about one in eight individuals will experience MDD in their lifetime, investors and researchers have leapt into the gap to find and fund better ways to match treatment to patients, develop non-pharmacological therapies and improve outcomes.
FDA’s real-world evidence draft expands data requirements
The U.S. FDA’s latest draft guidance for the use of real-world evidence (RWE) is a substantially heftier document than the 2017 final guidance that will shortly become obsolete, and buried in all those extra pages are a few key details.
Today's news in brief
BioWorld MedTech briefs for January 30, 2024.
Australia takes first steps toward meaningful reforms to health technology process
The biopharma industry lauded the first steps the Australian government has taken to widen access for drugs and devices via reforms to the current health technology assessment process that has remained unchanged for 30 years.
FDA draft for third-party EUA reviews lacks timeline commitments
The U.S. FDA has redrafted an existing guidance for third-party reviews of 510(k) submissions to include submissions under the emergency use authorization (EUA) program, which generally speaking should be good news. The problem with the draft is that these third parties will have to interact frequently and substantively with the FDA in EUA reviews, and the lack of prescribed timelines in the FDA draft suggests that while the use of third parties may help the agency manage any future EUA workloads, the total turnaround time for these applications might not be significantly better than was seen during the COVID-19 pandemic.
Nirsense develops wearable for monitoring cognitive state
Inventors affiliated with Nirsense LLC, are designing somatic and cerebral oximetry devices using functional near-infrared spectroscopy (fNIRS). They have filed for patent protection of wearable systems capable of detecting both optical and non-optical biometric properties of a user to determine their cognitive state.

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Digital health

Digital therapeutics seek new path forward in 2024
Asia-Pacific
After flying high in 2022, digital therapeutics (DTx) companies crashed to Earth in 2023 and scrambled to identify a path to profitability, or at least continued viability.
Yearly med-tech deal value soars 33%, M&As decline by 64%
Deals and M&A
Echoing trends seen last year, the med-tech industry concluded 2023 with a continued surge in deal value juxtaposed against a more substantial decline in M&A value. Deal value for the year, including licensings, collaborations and joint ventures, reached $10.63 billion from 1,656 deals, the highest...
Will European health care investment green shoots in 2023 yield results in 2024?
Financings
To say that 2023 continued to be a difficult fundraising environment for companies in Europe is an understatement. However, there were some green shoots and investors continued to back companies, seeing opportunities across the health tech, med-tech and biotech space.
Asia leads global efforts in precision health, AI-based models
Artificial intelligence
Asia continues its push to be the global leader with precision health and artificial intelligence/machine learning (AI/ML) models for diagnosing disease. Most health care systems in Asia’s major markets include universal health care coverage and are leaning toward electronic health records, paving...

Financings

With series A funds, IMU Bio’s Cytatlas identifies cell types and immune signatures
Cancer
IMU Biosciences Ltd. has raised £11.5 million (US$14.7 million) in a series A round to further develop and commercialize profiling technology that can identify from a blood sample which of more than 2,000 cell types are present in an individual’s immune system.

Newco news

Etcembly aims at cancer with AI-driven, rapid TCR engineering technology
Cancer
Etcembly emerged from stealth mode in August with something it regards as seemingly impossible: A machine learning platform that has the ability to predict and engineer – at never-seen-before scale and speed – T-cell receptors (TCR) that enable bispecific T-cell engager antibodies targeting cancer...

Brainaurora files for Hong Kong IPO to develop digital therapeutics
Financings
Brainaurora Medical Technology Ltd. has filed for an initial public offering (IPO) in Hong Kong to develop its digital therapeutics for the treatment of cognitive impairment diseases. The company claims to be the first in China to launch a digital therapeutics (DTx) product for cognitive...
A born listener: CNS startup Violet hones in on cellular cross-talk
Financings
The identification of new targets in diseases of the central nervous system (CNS) such as Alzheimer’s and Parkinson’s – conditions which continue to have significant unmet needs – has taken a small step forward as one company, Violet Therapeutics Inc., plans to put $10.6 million in seed funding...

Deals and M&A

Boston Scientific to acquire Axonics for $3.7B
Acquisition
Boston Scientific Corp. agreed to acquire neurostimulation company Axonics Inc. for $71 per share or $3.7 billion in total. Axonics focuses on stimulation of the sacral neve to treat overactive bladder and bowel dysfunction. It also offers a bulking agent to address stress urinary incontinence in...
Billion-dollar M&As: Bristol Myers buying Rayzebio; Astrazeneca taking over Gracell
Cell therapy
Two big pharma firms placed high offers on Dec. 26 to acquire companies focused on radiopharmaceuticals and cell therapies in what Evercore ISI analysts are calling a “good sign for the end of the year.”
Billion-dollar M&As: Bristol Myers buying Rayzebio; Astrazeneca taking over Gracell
Cell therapy
Two big pharma firms placed high offers on Dec. 26 to acquire companies focused on radiopharmaceuticals and cell therapies in what Evercore ISI analysts are calling a “good sign for the end of the year.”
Henry Schein bones up orthopedic commitment
Acquisition
Henry Schein Inc., long known primarily as a dental equipment distributor, added two deals to its 2023 roster that will expand its presence in the orthopedics market. The company agreed to acquire a majority interest in Trimed Inc., which focuses on solutions for treatment of the upper and lower...
Carl Zeiss Meditec agrees to buy Dutch Ophthalmic Research Center for €1B
Acquisition
Carl Zeiss Meditec AG reported it plans to buy Dutch Ophthalmic Research Center BV (DORC) from investment firm Eurazeo SE for approximately €985 million (US$1.08 billion).

Europe

Opto Biosystems develops sensors for monitoring brain activity
Neurology/psychiatric
In its first patenting, Cambridge, U.K.-based Opto Biosystems Ltd. is seeking protection for implantable sensors that may be used in systems to measure chemical, biological, or electrical signals in the central and/or peripheral nervous systems.

Asia-Pacific

New non-invasive imaging tech visualizes liver fat
Oncology
A new study published by researchers from the Tokyo University of Science (TUS) unveiled a new machine learning-aided, non-invasive imaging framework for rapid liver lipid visualization, which could help diagnose and treat steatotic liver diseases (SLD).

Seegene pushes ambitious DTx tech-sharing initiative with Microsoft
Diagnostics
In a post-pandemic world, South Korean molecular diagnostics firm Seegene Inc. is looking to ignite a new paradigm in the diagnostics business. Seoul-based Seegene is rolling out a new strategy of open innovation under its newfound initiative coined the “SG Onesystem,” which pledges to not only...
Wearable ‘hip-assist’ robots improve gait, balance in older adults
Orthopedics
A new wearable “hip-assist” robot developed by Samsung Electronics Co. Ltd. significantly improves gait, balance and dynamic movement in older adults and has the potential to not only enhance physical function but also mitigate the risk of falls.

Clinical

Orchestra bioelectronics tune hypertension in pacemaker patients
Cardiovascular
Orchestra Biomed Holdings Inc. randomized the first patient in the BACKBEAT pivotal study investigating the use of its atrioventricular interval modulation (AVIM) therapy as a treatment for patients with uncontrolled hypertension implanted with a...
Surmodics reveals positive data for its Sundance Sirolimus DCB
Conferences
Surmodics Inc. reported positive two-year data from the SWING trial, the first-in-human study to look at the safety of its Sundance Sirolimus drug-coated balloon (DCB) when used to treat occlusive disease of the infrapopliteal arteries. Results...
Xeltis’ vascular Axess graft implant sees no infection after one year
Conferences
One-year data from Xeltis AG’s first-in-human Axess vascular conduit trial showed outstanding results in patients with end stage renal disease who were deemed unsuitable for arteriovenous (AV) fistula creation. The results, presented at the...
Edwards, Medtronic likely to gain a beat on competition at TCT
Conferences
Medtronic plc got a jump on its cardiology competitors with big news ahead of the Transcatheter Cardiovascular Therapeutics (TCT) conference that starts on Oct 24 in San Francisco, with U.S. FDA approval of its Aurora extravascular implantable...
Humacyte’s phase II/III tissue graft data prompt talk of a BLA
Immune
Regenerative tissue developer Humacyte Inc. has posted positive top-line phase II/III results for its Human Acellular Vessel, a tissue-engineered graft consisting entirely of decellularized extracellular matrix, for vascular trauma repair. The...
Neuraxis looks beyond gut to apply IB-Stim in post-concussion syndrome
Gastrointestinal
Neuraxis Inc. has initiated a clinical study to evaluate the efficacy of its IB-Stim neuromodulation system in treating children with post-concussion syndrome (PCS). The aim is to see whether IB-Stim can ease the constellation of symptoms that...

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