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BioWorld - Sunday, March 26, 2023
Breaking News: Pharming’s PI3K-delta inhibitor, Joenja, wins first FDA nod in APDSBreaking News: A special invitation for new customers – 40% discount on any BioWorld subscriptionBreaking News: A special invitation for new customers – 40% discount on any BioWorld subscription
  • Robotic and human hands touching computer screen

    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

  • Today's news in brief

  • 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    The U.S. FDA’s December 2022 draft guidance for human factors (HF) information in medical device premarket filings is a complete do-over of a previous draft guidance from 2016, but the reaction from industry has been anything but cheerful. Several observers, including the Medical Device Manufacturers Association (MDMA), hammered the new draft guidance for its introduction of the concept of a critical task due to the expansive effect that would have on the need for human factors studies for medical devices.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.

BioWorld Insider Podcast

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.
Listen now

Digital health

  • Green traffic light

    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

    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...
  • Fire1's remote monitoring solution

    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...
More in Digital health

Today's news in brief

  • Appointments and advancements for March 24, 2023

  • Financings for March 24, 2023

  • In the clinic for March 24, 2023

  • Other news to note for March 24, 2023

  • Regulatory actions for March 24, 2023

Regulatory

  • More troubles for patients needing Datascope IABP units

  • US FTC: Apokyn suit has broad implications

  • US PTO offers blessed relief for small inventors in new patent fee schedule

  • Edwards joins tech companies in challenging US PTO’s standard for inter partes reviews

  • Implementation of EU diagnostics reg forcing drug trial delays

  • Delay of EU’s Medical Device Regulation now officially in force

  • FDA clears major upgrade to Elekta’s MR-Linac system

  • Medtronic wins CE mark for Affera dual-use cardiac ablation system

  • Woven Orthopedic FDA clearance for Ogmend implant ‘game changing’ for spine surgery

  • Biotech, med-tech exposure to US bank failures ‘limited’

Financings

  • Evaheart Yongrenxin Medical Instrument

    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.
  • Mvision raises €5.4M to accelerate cancer treatment

    Private
  • Vitestro raises $12.7M to bring its autonomous blood drawing device to EU market

    Private
  • Perspectum raises $55M to expand US footprint

    Series C
  • Doctorly prescribed $10M to expand its cloud computing system for German medical practices

    Private
More in Financings
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Newco news

  • DNA and data illustration

    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.
  • Quark Biosciences spins out cancer liquid biopsy company Pharus Diagnostics

    Asia-Pacific
  • Ampel’s genomic blood test detects and predicts severity of COVID-19

    Coronavirus
  • Curimeta launches partnership to unlock real-world data

    Financings
  • Biolab Sciences heals wounds with autologous gel-like graft

    Dermatologic
More in Newco news

Deals and M&A

  • Global handshake silhouette

    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...
  • Different mobile screen views of Somryst app

    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...
  • Hand between blocks

    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...
  • Asia at night from space

    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.
More in Deals and M&A

U.S.

  • Surgvision wins FDA clearance for Explorer Air II which will help fight cancer

  • Brainomix receives FDA clearance for stroke AI imaging software

  • Spectrawave secures FDA clearance for Hypervue intravascular imaging system

  • Baxter issues urgent Life 2000 correction for potentially fatal oxygen desaturation

  • Flowtriever System scores whopping 90% survival improvement during high-risk PE study

  • Biden budget plan takes aim at drug costs, boosts ARPA-H funding to $2.5 billion

  • Quidel wins first non-EUA COVID test authorization for Sofia rapid antigen test

  • Abbott’s Libre 2 and 3 gain clearance for AID integration

  • Late-breaking study results underscore positive real-world outcomes with Watchman FLX LAAC device

  • CMS surprises with earlier and broader CGM coverage, good news for Abbott and Dexcom

Europe

  • Solosmart - Sanofi

    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...
  • ECR session shows photon-counting CT to be a game changer

    Conferences
  • Remedee joins forces with Upsa to provide chronic pain relief

    Collaboration
  • United Imaging unveils first whole-body 5T MRI scanner

  • Tests unveiled for early detection and diagnosis of bladder cancer

    Clinical
More in Europe
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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.
  • Agilis Robotics moves closer to developing robots for endoscopic surgery

    China
  • Johnson & Johnson’s ablation catheter garners approval in China for atrial fibrillation

    Cardiovascular
  • First telemedicine drone delivers consultations in Pakistan

    Digital health
  • Investment in India’s med-tech industry draws mixed emotions

More in Asia-Pacific

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...
More in Clinical

BioWorld Insider Podcast

One-on-one with medical innovators

podcast microphone, sound waves on purple backgroundBreakthrough 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.


Recent episodes:

  • Cambrian carves out a new niche as it works to keep people from getting sick
  • Rethinking obesity: Fitness may be more directly linked to health than weight
  • Looking ahead to 2023: CEOs contemplate the new normal
  • Psychedelic evolution: Mindset Pharma looks to change mental health treatment
  • $1B+ biopharma deals keep values afloat, even amid muted volume
  • Extending the human lifespan
  • New therapies vie to change fatal course of amyotrophic lateral sclerosis
  • Biopharma’s correction? 2022 1Q investments are both up and down
  • Who advises the CDC on big COVID decisions and how’s that working out?
  • Long COVID: Potentially the next public health crisis

View all

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