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Home » Newsletters » BioWorld MedTech

BioWorld MedTech

May 21, 2021

View Archived Issues
Illustration of vascular system in the legs

Limflow reports 12-month data from PROMISE I study

Restoring blood flow to limbs is a challenging goal, given the minuteness of the peripheral vasculature. But there is a huge unmet need for patients with chronic limb-threatening ischemia (CLTI) – a severe form of peripheral artery disease in which patients face major amputation. Now, Limflow SA reports one-year data from the PROMISE I study shows its Percutaneous Deep Vein Arterialization System (pDVA) led to sustained amputation-free survival and wound healing in CLTI patients treated with the device. Read More
Deal-merger-money-lightbulb.png

Dariohealth expands into behavioral health with $30M Wayforward acquisition

Dariohealth Corp. agreed to acquire Psyinnovations Inc. (dba Wayforward), a behavioral health digital platform, for $30 million. The deal represents Dario's second of 2021, following the acquisition of the digital musculoskeletal company Upright Technologies Ltd. in January. The Wayforward transaction calls for $25 million at closing, with $6 million of that in cash and $19 million in shares of Dario common stock valued at $21.09 per share. In addition, Wayforward will receive another $5 million, if behavioral health revenues exceed a certain threshold in 2022. Read More
Regulatory-US-FDA-HQ.png

FDA eyes greater degree of specificity regarding materials in device labeling

The FDA’s November 2019 two-day hearing regarding the use of metals in medical devices generated at least one actionable recommendation, namely that manufacturers disclose all materials used in devices in product labels. The agency has reacted to that recommendation in the form of a discussion paper that proposes to require that product labels provide a deep level of detail regarding the materials found in the device, a notion that received the backing of industry during the November 2019 hearing. Read More
Flag of Australia, sky background

Australia nearing completion of medical device reforms

PERTH, Australia – As D-Day approaches for the European Medical Device Regulations (MDR), Australia is also nearing completion of implementing its own medical device reforms, which closely mirror the EU MDR. “We had to look at aligning as close as possible with the EU system, but we’ve had to align with a moving, incomplete and delayed target, and the TGA asked us to move ahead of the EU reforms,” said John Skerritt, deputy secretary, Health Products Regulation for the Therapeutic Goods Administration (TGA), during the recent Ausmedtech virtual conference. Read More
Lung cancer illustration

Both ORRs in the water: Cullinan ASCO data near, J&J’s bispecific Rybrevant approved in NSCLC subset

The FDA’s approval for Johnson & Johnson (J&J) of Rybrevant (amivantamab-vmjw) not only brings the first treatment for adults with non-small-cell lung cancer (NSCLC) whose tumors bear EGFR exon 20 insertion mutations, but also sets a high overall response rate bar for other developers in the space. Read More
Brain and blood cells

ASGCT 2021: Engineering blood cells can treat brain diseases

Collectively, lysosomal storage disorders (LSDs) are caused by malfunctions in metabolic enzymes in the lysosome system. Depending on which enzyme is missing, toxic metabolites accumulate. While the LSDs are highly heterogenous – even within one disease, presentation can vary widely – neurodegeneration is a common feature in these disorders. Read More

Appointments and advancements for May 21, 2021

New hires and promotions in the med-tech industry, including: AG Mednet, Novasignal. Read More

In the clinic for May 21, 2021

Clinical updates, including trial initiations, enrollment status and data readouts and publications: Fast Biomedical, Freenome, Polyganics. Read More

Med-tech gainers and losers for May 17-21, 2021

The top 10 med-tech stock gainers and losers for the week. Read More

Other news to note for May 21, 2021

Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Anthem, Clinical Enterprise, Diversa, Edwards Lifesciences, Eurofins, Grupo Suprimed, Humacyte, Indica Labs, Inspire MD, Inspire Medical Systems, Mdxhealth, Neovasc, Novacyt, Sanuwave, Viracor. Read More

Regulatory actions for May 21, 2021

Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Guardant Health, Ito. Read More

BioWorld MedTech Patent Highlights: Week 19

BioWorld MedTech presents Patent Highlights, an excerpt of the most important med-tech patents from this week's Cortellis Patents Gazette. Read More

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