Biospectal receives CE mark for blood pressure monitoring app
Biospectal SA has received a CE MDR class IIa medical device certification for its optical fingertip blood pressure monitoring app, Optibp. The device records fingertip blood flow optically and transforms the information into a pulse wave that it analyzes to estimate blood pressure.

Today's news in brief
BioWorld MedTech briefs for December 8, 2023.

Biospectal receives CE mark for blood pressure monitoring app
Biospectal SA has received a CE MDR class IIa medical device certification for its optical fingertip blood pressure monitoring app, Optibp. The device records fingertip blood flow optically and transforms the information into a pulse wave that it analyzes to estimate blood pressure.
Today's news in brief
BioWorld MedTech briefs for December 8, 2023.
FDA facing a ‘somewhat unimaginable’ volume of applications for LDTs
The U.S. FDA’s draft rule for lab-developed tests (LDTs) has proven to be every bit as controversial as expected, although the controversy is only marginally about the workload that would come with rulemaking.
‘Oh when the government goes marching in’ a rising US threat?
After a nine-month review, the Biden administration is preparing to go where all other U.S. administrations have refused to trod. In releasing a draft framework to help federal agencies decide whether to exercise a federal march-in on patent rights protecting taxpayer-supported drugs and other inventions, including medical devices.
Med-tech financings mark YOY decline, November sees more than $1B raised
Med-tech financings surpassed $1 billion again in November, with transactions totalling $1.02 billion for the month. Though a decline from the $1.23 billion raised in October, the value is up from September’s $645.75 million.

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Digital health

Apollo brings better sleep and stress relief with Smartvibes
Neurology/psychiatric
Apollo Neuroscience Inc. recently introduced a new software called Smartvibes for its Apollo wearable device to help people lower their stress levels and sleep better. There are a growing number of wearable technologies that have sensors that continuously measure physiological signals to help...
Vicentra launches hybrid closed-loop diabetes system
Diabetes
With hybrid closed-loop systems for automated insulin delivery increasingly being seen as life changing for people with diabetes, Vicentra BV has teamed up with Diabeloop SA and Dexcom Inc. to launch a system to help people with type 1 diabetes manage their condition.
Ausbiotech panelists explore digital health’s role in health care
Asia-Pacific
Digital health is on the cusp of transforming health care, and it’s not just about electronic health records, it’s about connecting medical devices with data and artificial intelligence and machine learning to improve health outcomes, panelists said during the Ausbiotech conference held in...
Sofinnova raises $200M for digital medicine fund
Financings
Sofinnova Partners hauled in $200 million in investment for its digital health fund as investors’ appetite for companies developing solutions for health care using digital technology continues to grow.

Financings

Intuitive Ventures raises $150M to support med-tech startups
U.S.
Intuitive Ventures, the investment arm of Intuitive Surgical Inc., closed a $150 million fundraising round for its second fund, which will focus on investments in startups in three areas: precision diagnostics and interventions, digital ecosystems and improving health care access and coordination....

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

Med-tech M&As continue decline while deal value soars nearly 50% YOY
Analysis and data insight
While med-tech deals were well below average the past two months, cumulative values are up 47.67% over the same period last year. Through October, the total worth of med-tech deals reached $9.97 billion, rising from $6.75 billion in the corresponding period in 2022.
Despite September slowdown, med-tech deal value hits $9.83B through Q3
Analysis and data insight
Med-tech deals are up 49.01% year over year, with the industry raising $9.83 billion through September in 2023, up from $6.59 billion in the same time frame last year. The number of deals, meanwhile, has decreased from 1,510 through Q3 2022 to 1,278 this year.
EU orders Illumina to sell Grail or face further fines
Regulatory
The European Commission (EC) has ordered Illumina Inc. to sell Grail Inc. after it closed the acquisition without approval from EU regulators. The EC said that if Illumina fails to comply with the order, the company faces fines of up to 5% of its daily aggregate revenue or up to 10% of its annual...
SK Bioscience, Vaxxas partner to develop needle-free typhoid vaccine
Infection
SK Bioscience Co. Ltd. and Vaxxas Pty. Ltd. have entered into a joint development agreement that could revolutionize vaccines by developing a vaccine-delivery device combination product using Vaxxas’ high-density microarray patch (HD-MAP) coupled with SK Bioscience’s typhoid vaccine, Skytyphoid.
On the SPAC track: Slowdown continues with Ross/Aprinoia sputter
Neurology/psychiatric
The first special purpose acquisition company (SPAC) merger announced in 2023 has fallen apart. Aprinoia Therapeutics Inc. and Ross Acquisition Corp. II mutually agreed to call off the merger that had been valued at $280 million. The failed deal is part of a larger trend that has gained momentum in...

Europe

Omini develops blood testing platform for heart failure
Cardiovascular
Omini SA hopes that the multiplexed blood testing platform it is developing will transform the lives of patients suffering from heart failure. With its multiplex, sensor-based testing strip that simultaneously measures four key biomarkers from a single drop of blood, the company’s technology should...

Asia-Pacific

Medtronic scraps plans to buy wearable insulin patch maker Eoflow
Drug design, drug delivery and technologies
One of the largest med-tech deals of 2023 was wiped off the charts when Medtronic plc terminated a $738 million agreement to acquire South Korean wearable insulin patch maker Eoflow Co. Ltd., citing “multiple breaches” under its agreements, on Dec. 6.

Broncus acquires Chinese pulmonary device company Hangzhou Jiangliang
Merger
Broncus Holding Corp. subsidiary Broncus Hangzhou is acquiring Chinese medical device company Hangzhou Jingliang in the form of an equity transfer agreement for ¥5.4 million (US$758,000). The move will strengthen Broncus’ R&D capabilities in the flexible robotic space and will allow the company to...
Metal-enhanced fluorescence system quickly detects viral infections
Infection
South Korean researchers from the Gwangju Institute of Science and Technology (GIST) developed a new fluorescence-based lateral-flow immunoassay (LFI) enhanced with gold nanorod (GNR)-based probes to detect viral infections like the influenza A virus.

Clinical

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...
EDEN trial shows DBS improves movement in stroke patients
Medical devices and technologies
A first-in-human clinical trial conducted by researchers at the Cleveland Clinic demonstrated that deep brain stimulation (DBS) applied to the dentate nucleus region of the cerebellum could help patients recover function in their upper extremities...

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