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Home » Newsletters » BioWorld MedTech

BioWorld MedTech

May 15, 2024

View Archived Issues
Recor Medicaal Paradise renal denervation catheter

Renal denervation, no more excuses to adoption

There should be no more excuses to the adoption of renal denervation (RDN) as a treatment for hypertension given the recent approval by the U.S. FDA of two technologies and a range of guidelines recommending the therapy, delegates heard at the EuroPCR conference in Paris. In a discussion on the technology, panelists argued that on the back of solid evidence, RDN should be offered as a treatment given that the therapy is a safe method to reduce high blood pressure. Read More
Neural Ice

Brixton comforted by $33M series B for pain relief therapy

Brixton Biosciences Inc. closed a $33 million series B funding round that it plans to immediately use to pursue two clinical trials to evaluate the use of its Neural Ice nerve block for knee pain. The injectable product received U.S. FDA breakthrough device designation in October. Read More
Chanelle Case Borden pipetting DNA samples into a tube for polymerase chain reaction.

FDA’s Califf calls on labs to ‘wake up and develop better tests’

The U.S. FDA’s final rule for regulation of lab-developed tests promises to remain controversial for the foreseeable future, but FDA commissioner Robert Califf said that many of these tests have been shown to be less than adequately reliable. Califf said that one of the effects of the final rule is that it will force clinical labs to “wake up and develop better tests,” if only because compliance and enforcement regimes will soon be applied to clinical labs. Read More
Stereotaxis robotic magnetic navigation (RMN) system

Stereotaxis to buy EP catheter maker Access Point Technologies

Stereotaxis Inc. said it is buying electrophysiology catheter maker Access Point Technologies EP Inc. to enhance its minimally invasive endovascular surgical robotics technology offerings. Read More
eye-tech.png

US legislation for AI described as ‘long-term process’

Artificial intelligence recently roiled the regulatory world, but the U.S. Congress has yet to dive into the task of legislating on the concept. Barrett Tenbarge, general counsel for Sen. Bill Cassidy (R-La.) told an audience here in the nation’s capital that while the Senate is considering several legislative proposals, the desire to avoid legislation that will create as many problems as it solves suggest that legislative development “is a long-term process.” Read More

Biosecure Act fine-tuned, new health care tariffs in the offing

As it gets fine-tuned, the Biosecure Act is becoming more than just a topic of conversation in the halls and meeting rooms of the U.S. Capitol. Reps. Brad Wenstrup (R-Ohio) and Raja Krishnamoorthi (D-Ill.) formally introduced a new version of the Biosecure Act in the House May 10 as a defense against China’s national security laws requiring all Chinese firms to share any requested data with the Chinese Communist Party, including biotechnology companies that collect, test and store American genomic data. Read More

Appointments and advancements for May 15, 2024

New hires and promotions in the med-tech industry, including: Enhanc3D Genomics Ltd., Geneoscopy Inc. Read More

Financings for May 15, 2024

Med-tech firms raising money in public or private financings, including: Aethlon Medical, T2 Biosystems. Read More

In the clinic for May 15, 2024

Clinical updates, including trial initiations, enrollment status and data readouts and publications: Enable Biosciences. Read More

Other news to note for May 15, 2024

Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Corepath, GTC, IDT, Molecular Health, Neuronetics, Rapid Medical, Sevaro. Read More

Regulatory actions for May 15, 2024

Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Acclaro, Oxehealth, Qiagen, Roche. Read More
cybersecurity-data-lock.png

BioWorld reader feedback needed: Cyberattack impact survey

The recent cyberattack on Change Healthcare, a part of the Unitedhealth Group, crippled reimbursement claims processing for thousands of providers for several weeks and potentially exposed troves of patient data. Congressional committees are investigating the attack, its scope, and Unitedhealth’s response. Please take a few minutes to fill out this short survey to help BioWorld understand how your company is responding to these threats. You can click through to the questions here. Read More

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