Huma Therapeutics receives multi-condition EU Class IIb approval for SaMD product
Huma Therapeutics Ltd. received the first EU Class IIb approval for a software as a medical device (SaMD) product, winning the certification for its system for collecting and analysing patient data across multiple disease indications, the company reported. The approval will open up the market for digital health apps, with customers now able to link into Huma’s underlying technical platform to develop their own digital health apps and companion diagnostics, avoiding the need to then get their own, separate EU medical device certification.

Huma Therapeutics receives multi-condition EU Class IIb approval for SaMD product
Huma Therapeutics Ltd. received the first EU Class IIb approval for a software as a medical device (SaMD) product, winning the certification for its system for collecting and analysing patient data across multiple disease indications, the company reported. The approval will open up the market for digital health apps, with customers now able to link into Huma’s underlying technical platform to develop their own digital health apps and companion diagnostics, avoiding the need to then get their own, separate EU medical device certification.
FDA’s human factors draft draws fire for introduction of ‘critical task’ concept
The U.S. FDA’s December 2022 draft guidance for human factors (HF) information in medical device premarket filings is a complete do-over of a previous draft guidance from 2016, but the reaction from industry has been anything but cheerful. Several observers, including the Medical Device Manufacturers Association (MDMA), hammered the new draft guidance for its introduction of the concept of a critical task due to the expansive effect that would have on the need for human factors studies for medical devices.
Today's news in brief
BioWorld MedTech briefs for March 24, 2022.
Aiomic secures funds to combat postoperative complications
Startup Aiomic ApS received a capital injection in the form of a €1.3 million (US$1.4 million) convertible loan from Denmark’s Bioinnovation Institute (BII) that will allow the company to further develop and commercialize its artificial intelligence (AI)-driven Aiomic360 platform, which is designed to reduce the number of postoperative complications.
Bellaseno and Evonik start commercialization of 3D-printed bioresorbable implants
Bellaseno GmbH and Evonik Industries AG joined forces to commercialize 3D-printed scaffolds used in bone regeneration. The scaffolds are made with Evonik’s Resomer polymers to address large and complex bone defects as an alternative to frequently less stable conventional methods.
Previse snags $3M in seed funding, debuts esophageal cancer test
Previse, formerly known as Capsulomics Inc., raised $3 million in seed financing to support the launch of its first laboratory-developed test (LDT), Esopredict. The precision medicine test is designed to detect Barrett’s esophagus (BE) and predict which BE patients will progress to esophageal cancer.
BioWorld MedTech Patent Highlights: Week 11
BioWorld MedTech presents Patent Highlights, an excerpt of the most important med-tech patents from this week's Cortellis Patents Gazette.

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As James Peyer, the CEO of Cambrian Biopharma Inc., watched his grandfather fail every cancer treatment and pass away, he also saw the structure of his future company being born. Waiting until people became sick was the wrong way to treat disease, he found. Instead, Cambrian was created to develop anti-aging therapies, a unique business model that fits the new field of geroscience.

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Digital health

Viz.ai snares FDA clearance for new algorithm for abdominal aortic aneurysm
U.S.
One way to strike fear into patients and cardiologists alike is to merely mention the abdominal aortic aneurysm (AAA), an event that claims more than 10,000 lives per year in the U.S. alone. That death count might fall substantially going forward thanks to the U.S. FDA’s award of a 510(k) for the...
Digital health investments continue to grow in EU
Europe
Early-stage venture capital firm Karista SAS reported the third edition of its European digital health funds mapping report. This mapping included all funds with global headquarters in France, Germany, Spain, Italy, the U.K., Netherlands, Austria, Luxembourg, Belgium and the Nordics.
Resilient develops wearable device to reverse opioid overdoses
Substance use and poisoning
Free, no-prescription-required access to naloxone injectors and nasal sprays has reduced deaths from opioid overdoses by 11% in some communities, but they only work if someone with the reversal agent is available when a person overdoses. Many times, unfortunately, opioid users are alone when an...
Andera, Novo lead $25M financing for Fire1
Financings
Andera Partners and Novo Holdings A/S led a financing round which raised $25 million for Fire1 Ltd. and will accelerate the development of the company’s remote monitoring technology that improves outcomes for heart failure patients. Andera and Novo are new investors in Fire1 and were joined in the...

Financings

Yongrenxin Medical nets $100M in financing for heart failure platform
Private
Yongrenxin Medical Instrument Co. Ltd. raised nearly $100 million in a series A funding round to build a health platform to treat heart failures. Sinovac Biotech Ltd. led the round.

Newco news

Startup Enhanc3D raises £10M for high-res genome mapping platform
Medical devices and technologies
Enhanc3D Genomics Ltd. has raised £10 million (US$11.3 million) in a series A round to advance development of its Genlink3D technology for directly linking gene regulators in non-coding DNA to their target protein coding genes.

Spinoffs keep up dizzying pace with Medtronic separation
U.S.
After years of aggressive acquisitions, Medtronic plc joined 3M Co., General Electric Co. and Johnson & Johnson in rationalizing its business by splitting into more focused enterprises. Medtronic will separate its patient monitoring and respiratory therapy groups into a new company with projected...
Axoft launches with $8M for brain-machine interface implants
Financings
Axoft Inc. emerged from stealth mode with an $8 million seed round led by The Engine, the Massachusetts Institute of Technology’s venture spinout for early-stage tech startups. The funds will be used to conduct preclinical studies and scale up prototypes of its supple brain implant technology.

Deals and M&A

Detection Technology acquires Haobo Imaging to enter flat panel detector market
Acquisition
Detection Technology plc has agreed to acquire X-ray flat panel detector provider Shanghai Haobo Imaging Technology Co. Ltd. to expand in the thin-film transistor (TFT) flat panel detector market. Shanghai-based Haobo Imaging was valued at around €14 million (US$15 million). Finland-based Detection...
Cleveland Clinic teams up with IBM on quantum computer for life science research
In an age of overwhelming volumes of data that don’t fall together effortlessly into a lucid representation of reality, computational power is often the vital ingredient in leveraging existing data to push the frontiers of medicine. The Cleveland Clinic and IBM unveiled a quantum computing center...
Slow uptake, roiled markets take a bite out of Pear: PDT company seeks strategic alternatives
U.S.
March 17 brought neither good luck nor good news to Pear Therapeutics Inc. Just prior to the opening bell, the prescription digital therapeutics company reported that it had engaged MTSA Health Partners LP to explore strategic alternatives for the company. In addition, Pear filed an 8-K with the...
Icahn launches proxy battle to end Illumina’s continued pursuit of Grail
Acquisition
From Carl Icahn’s point of view, Illumina Inc.’s desired reintegration of its former spinoff is more a poisoned chalice than a holy Grail. In his opening salvo to a proxy fight, Icahn published an open letter March 13 to other Illumina shareholders referencing the “extreme displeasure” of investors...
Olympus in $370M buy of Taewoong to expand in gastrointestinal endotherapy field
Asia-Pacific
Olympus Corp. has acquired Taewoong Medical Co. Ltd. in a $370 million deal to expand its gastrointestinal (GI) endotherapy product portfolio.

Europe

Sanofi launches its first smart data sensor that records insulin injections in real time
Sanofi SA is launching its first connected data collector for recording insulin injection in real time. The launch was reported at the Francophone Diabetes Society (SFD) congress in Montpellier, France this week. Distribution will begin via the network of 21,000 pharmacies throughout France. The...

Asia-Pacific

Neuboron performs boron neutron capture therapy in Chinese trial
China
In its first trial designed to evaluate boron neutron capture therapy (BNCT) in the treatment of advanced refractory malignant tumors, Neuboron Medtech Ltd. has performed 14 irradiations on a dozen patients.

High bilirubin levels worsen stroke outcomes by aggravating brain damage
Neurology/Psychiatric
High levels of bilirubin exacerbated damage to neurons in the brain caused by a stroke by binding to the TRPM2 channel, which helped regulate cell death among other processes. The research, published March 14, 2023, in Neuron, showed that blocking the binding site for bilirubin in a mouse model led...
Venus Medtech moves Liwen RF China trial forward
Clinical
Venus Medtech (Hangzhou) Inc. completed the enrollment of patients for a confirmatory clinical trial using its Liwen RF ablation system for the treatment of hypertrophic cardiomyopathy (HCM), reaching 128 patients in 20 hospitals in mainland China since January 2021.

Clinical

Ancora Heart’s Accucinch improves heart failure outcomes
Conferences
Ancora Heart Inc. reported 12-month data showing its Accucinch system significantly improves outcomes in heart failure (HF) patients, including positive changes in cardiac structure and function. The results, presented at the Technology and Heart...
Rare diseases yield genomic secrets through new computational approach
Rare diseases
By adapting computational methods for dealing with large volumes of data, and slimming down that data, researchers at the Icahn School of Medicine at Mount Sinai have discovered previously unknown genetic associations with 19 rare diseases, and...
Age no longer a sticking point? Artificial pancreas system helps very young children with diabetes
Diabetes
An artificial pancreas system that draws on research conducted at the University of Virginia to effectively combine Dexcom Inc.’s continuous glucose monitor and Tandem Diabetes Care Inc.’s artificial intelligence-enabled insulin pump works...
Research possible harbinger for broader intervention guidelines treating AS
American College of Cardiology
Two research studies by Egnite Inc. presented at the American College of Cardiology Conference (ACC) could shake up the scope of how aortic stenosis (AS) is understood and treated by physicians.
Noah Medical reveals first use of robotic Galaxy system humans
Medical robotics startup Noah Medical Inc. is conducting a first-in-human clinical trial to assess the safety and feasibility of its Galaxy system to improve lung cancer diagnosis. The device received U.S. FDA clearance on March 1 for use in...
Inspiring results: 65% reduction in COPD admissions with Spire’s Health Tag
One company has developed a promising device and care model to reduce the exacerbations of chronic obstructive pulmonary disease (COPD) that often send patients to the hospital and contribute to accelerated disease progression. Patients who used a...

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