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Minute Insight: Maestro Cues The Music With CE Mark For Moon Surgical

The Paris-based start-up has picked up a CE mark for the latest generation of its Maestro system, a tool designed to make laparoscopic surgery easier and safer.

Minute Insights Robotic Surgery

Representatives Press CMS On Coverage Of Innovative Devices

Medicare coverage of innovative and life-saving devices, drugs and diagnostics were the focus of a 19 September Congressional hearing during which representatives pressed for swifter and more predictable paths to reimbursement.

Policy Legislation

Exciting New Opportunities Launched In UK For Innovative Products As IDAP Gets Underway

Medtech developers have just over a month to apply for the pilot phase of a program offering regulatory and practical support to accelerate innovative product access to the UK NHS.

Europe United Kingdom

Medtech DEI Experts Talk Shop: ‘It’s Going To Transform Businesses’

An all-female panel of medtech DEI leaders at the LSX Congress USA conference discussed the importance of diversity and inclusion in research, clinical trials, product development and services to advance health equity as well as fundamental business goals.

Diversity & Inclusion Business Strategies

FDA Updates Breakthrough Devices Guidance To Improve Health Equity

The US FDA has updated its final guidance to clarify use of the Breakthrough Devices Program in advancing health equity. The voluntary program was created to speed up the process of getting innovative medical devices to patients that treat life-threatening or debilitating diseases.

FDA Policy

Minute Insight: Paige Strikes It Big With Microsoft Partnership

The two tech companies – one software giant, the other focused on oncology – will work together on what will likely be the largest artificial intelligence model of its kind.

Minute Insights Artificial Intelligence

FDA Issues Guidance On Biocompatibility Testing For Devices That Make Contact With The Human Body

The US FDA has issued final guidance to assist developers in preparing various applications for medical devices that come in contact with the human body. The guidance also seeks to clarify the use of international standards in assessing device biocompatibility.

FDA Guidance Documents

Market Fast Track Or Regulatory Trap? Consultant Ken Block On US FDA’s Breakthrough Devices Program

Ken Block of Ken Block Consulting weighs in on the FDA’s Breakthrough Devices Program, its implications for raising capital, achieving speedier market access, and inviting more intensive regulatory scrutiny in this interview with Medtech Insight.

FDA Regulation

Click Therapeutics And Indivior Collaborate On Prescription Digital Therapeutics In Substance Use Disorder

Click Therapeutics and Indivior will develop a digital solution for treating substance use disorders, starting with opioid use disorders. Click already signed partnership deals with Otsuka and Verily and Boehringer Mannheim to co-develop digital therapeutics for patients with schizophrenia and major depressive disorder.

Artificial Intelligence Behavioral Health

FDA Issues Three Draft Guidance Documents In Ongoing Effort To Improve 510(k) Submissions

As part of its ongoing effort to modernize its premarket notification 510(k) program, the US FDA has issued three draft guidance documents it says will improve the safety of critical medical devices and strengthen the submission process.

FDA Policy

Digital Health Roundup: VR, AI Trends In Rehabilitation; Cybersecurity Regulations; Medicare Updates

In this month’s Digital Health Roundup, Medtech Insight’s Marion Webb highlights VR, AI and other high tech trends in rehabilitation and gait training. Hannah Daniel discusses cybersecurity updates such as the new NIST published draft for an updated version of the Cybersecurity Framework, a recent report by Health-ISAC, and an interview with MedCrypt’s Naomi Schwartz about the upcoming FDA cybersecurity regulations for premarket approvals.

Digital Health Artificial Intelligence

Beta Bionics Secures $100M In Series D Funding To Expand Artificial Pancreas Tech

After receiving US FDA clearance in May, Beta Bionics secured $100m in financing which is expected to be used to commercialize its iLet Bionic Pancreas and “further develop and test the bi-hormonal bionic pancreas.”

Financing Diabetic Care

Cardio Catch-Up: Advisory Panel Gives Recor Momentum Toward US Launch Of RDN System

The majority of FDA’s circulatory systems devices panel agreed that ReCor’s Paradise ultrasound renal denervation system offers a safe and effective therapy for patients with hypertension. The panel’s endorsement means ReCor will likely be the first company to reach the US market with an RDN system.

Advisory Committees Clinical Trials

Cardio Catch-Up: Medtronic Still Has Work To Do On RDN After FDA Advisory Panel

FDA’s circulatory system advisory panel narrowly voted against Medtronic’s Symplicity Spyral, because one of the pivotal trials of the radiofrequency renal denervation system missed its primary endpoint and the patient population evaluated in the trial does not match the requested indication.

Advisory Committees Approvals

Danaher To Acquire Abcam For About $5.7Bn, Expand Services For Life-Science Industry

After a summer of speculation about who will close the deal with Abcam, tech leader Danaher came out ahead and will acquire Abcam for $24 a share.

M & A In Vitro Diagnostics

Analyst Expects Roche’s Newly FDA-Cleared Insulin Patch Pump Will Have ‘Limited Impact’

Roche received FDA clearance for its Solo insulin patch pump, but is expected to face significant barriers to entry in the highly competitive US insulin pump market.

Research & Development Commercial
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