Medtech Insight is part of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC’s registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By

UsernamePublicRestriction
UsernamePublicRestriction

Featured Stories

Philips Strikes Record High Number Of Long Term Health Care Partnership Deals

Royal Philips closed out the first year of COVID-19 with 7% revenue growth in the fourth quarter. CEO Frans van Houten says low single digit growth is the target for fiscal 2021.

Commercial Sales & Earnings Medical Device

Biden Extends Helping Hand To Small US Manufacturers, Vendors With ‘Made In America’ EO

The president’s executive order aims to give smaller companies a leg up over foreign competitors, among other objectives.

Manufacturing Policy United States

FDA To Hold Postponed 3-Day Pediatric Device Workshop In February

The US agency plans to hold a virtual workshop that will use breakout sessions to get stakeholder feedback on specific hurdles preventing more pediatric devices coming to market.

Regulation Policy Clinical Trials

Medtronic Looks To Adaptive DBS To Advance Treatment Of Parkinson’s Disease

Medtronic is sponsoring a trial to evaluate its adaptive deep brain stimulation technology, a unique feature of the Percept PC device for treating Parkinson’s disease.

Clinical Trials Business Strategies Research & Development

Regulatory Science Tools For Phantoms, Lab Methods Added To US FDA Catalog

The regulatory tools are for use in medical device development.

FDA Medical Device Regulation

Boston Scientific Bets Big On Monitoring; Buys Preventice For Up To $1.25Bn

The deal is the fourth major acquisition in the remote monitoring market in the last five weeks after Philips acquired BioTelemetry and Capsule and Hillrom bought Bardy Diagnostics.

M & A Digital Health Cardiovascular

QUOTED. 26 January 2021. Jon Otterstatter.

Boston Scientific’s purchase or Preventice is the fourth major acquisition in the remote monitoring market in the last five weeks, and drew praise from Preventice CEO Jon Otterstatter.

Quoted M & A Digital Health

Device Week Podcast




Discussed in this episode:


Start-Up Spotlight: CorWave Takes Inspiration From Nature To Tackle Heart Failure

Following a €2.5m award from the European Commission’s EIC Accelerator Program, Paris based CorWave has become the first EU company to obtain EIC fun...

Start-up Spotlight Cardiovascular

Recent Tweets from Medtech Insight

Latest from PR Newswire


Click here to access further medical device and diagnostics news.


 

Policy & Regulation Explore this Topic

Set Alert for Policy & Regulation

Lawyer: Biden Reg Freeze Puts On Ice Potential Premarket Review Waivers For 84 Device Types

King & Spalding partner Kyle Sampson tells Medtech Insight that a joint US HHS/FDA notice that could exempt a plethora of medical devices from premarket review falls under a recent regulatory freeze from the Biden administration.

Policy FDA Review Pathway

FDA Sets New Restrictions For Authorized N95 Decontamination Systems

After reviewing real-world data, the US agency says the decontamination systems should only be used for compatible facemasks and should not be used to clean a mask more than four times.

Compliance Coronavirus COVID-19 Enforcement

Latest From Policy & Regulation

Warning Letter Roundup & Recap – 26 January 2021

No device-related warning letters were released by the US FDA the week of 26 January.

Device Warning Letters FDA

Biden Signs COVID-19 Relief EO To Expand And Accelerate Testing, Fill PPE Shortages

Under an extensive COVID-19 plan and executive order signed on 21 January, the US president explained how he’ll beef up testing and manufacturing of medtech to fight the virus.

Policy Leadership

AdvaMed: Medtech Industry Wants Seat At Biden’s Coronavirus Response Table

The largest medical device lobby group in the US says it’s open to the administration’s decision to invoke the Defense Production Act to boost testing and PPE production, but wants to be consulted on how to implement it.

Policy Companies

COVID-19: FDA Schedules 4 More Virtual Town Halls Through February

The US agency has announced another month of webinars aimed at labs and manufacturers that are (or have) developed diagnostic tests for the novel coronavirus.

Diagnostics FDA

Q&A: Renalytix AI Prez Explains How MCIT Rule Will Aid Kidney Product Coverage By CMS

Tom McLain tells how the new MCIT policy from the US Medicare agency – and winning support from Congress – will guarantee Medicare coverage for his company’s product, an artificial intelligence-enabled in vitro diagnostic platform.

Policy Medicare

MDIC Proposes Real-World Evidence Framework For Sponsors To Hasten Product Applications

The document from the Medical Device Innovation Consortium aggregates external data sources, various statistical methods and lays out other considerations for sponsors to help speed up and bolster a premarket product application to the US FDA.

Regulation Research & Development

Quality Control & Compliance Explore this Topic

Set Alert for Quality Control

US FDA Announces 99 New Or Updated Consensus Standards

The updates reflect changes to standards on medical electrical equipment and a wide range of device types.

Standards Quality Control

UK Responsible Person, EU ARs and Northern Ireland: The View From MedTech Europe

The UK responsible person is the UK equivalent of the Authorized Representative in the EU. MedTech Europe’s Jesús Rueda gives an update on the early experiences of medtech manufacturers seeking to comply with the UK’s new standalone regulations.

EU United Kingdom

EU Notified Body Association Takes Steps To Allay EC’s Virtual Audit Fears

The European Commission has reluctantly allowed virtual audits in the context of new MDR and IVDR. The EU notified body association is helping the collective effort to meet its strict requirements.

Europe EU

OUTLOOK 2021 IS LIVE

Access In Vivo’s annual showcase of special features and industry league tables, including Scrip 100

VIEW 2021 RANKINGS

Commercial Explore this Topic

Set Alert for Commercial

Execs On The Move: Promotions At Agilent And CHF Solutions; New Chief At Zimmer

CHF Solutions adds “CEO” to its president’s job title; Agilent VP of business development promoted to senior VP; Zimmer hires chief transformation officer; and more.

Commercial Appointments Medical Device

Latest From Commercial

Device Week, 21 January 2021 – EY M&A Firepower; JPM, NANS Events Highlights; CorWave Profile

In this week’s podcast, Medtech Insight's managing editor Marion Webb and deputy editor Reed Miller discuss highlights from the recent J.P. Morgan Healthcare and North American Neuromodulation Society (NANS) virtual meetings. And London-based reporter Barnaby Pickering profiles start-up CorWave SA, which developed a left ventricular assist device for treating end-stage heart failure.

Device Week Financing

Fines, But No Prison Time For Ex-Acclarent Execs

The sentences are the latest chapter in a long-running off-label marketing case.

Commercial Legal Issues

Thermo Fisher Scientific, Hillrom To Acquire Diagnostics Companies To Bolster Portfolios

Thermo Fisher Scientific has agreed to buy Mesa Biotech for $450m in cash and Hillrom will acquire Bardy Diagnostics for $375m in cash. Both deals will add complementary digital health solutions, which may be a continued trend in 2021.

M & A Coronavirus COVID-19

CMS Extends National Medicare Coverage For Transcatheter Mitral Valve Repair

Medicare now covers transcatheter edge-to-edge repair for both functional and degenerative mitral regurgitation under specific conditions.

Medicare Clinical Trials

Ericsson Is Readying For A 5G Health Care Revolution

A top executive at the Swedish company spoke with Medtech Insight about how the mobility and data reliability of 5G cellular technology will change how medtech manufacturers design their products.

Digital Health Business Strategies

DJO Thinks Trilliant Is Brilliant, Announces Acquisition

DJO Global will buy Trilliant Surgical to further its ongoing expansion into the US foot and ankle market.

M & A Orthopedics

Clinical R&D Explore this Topic

Set Alert for Clinical R&D

New Trial Shows BENEFIT Of J&J/Auris’ Monarch Bronchoscopy Platform

New published results demonstrate J&J/Auris’ robotic is safe and effective at diagnosing peripheral pulmonary lesions.

Robotic Surgery Clinical Trials Cancer

Latest From Research & Development

Device Week, 21 January 2021 – EY M&A Firepower; JPM, NANS Events Highlights; CorWave Profile

In this week’s podcast, Medtech Insight's managing editor Marion Webb and deputy editor Reed Miller discuss highlights from the recent J.P. Morgan Healthcare and North American Neuromodulation Society (NANS) virtual meetings. And London-based reporter Barnaby Pickering profiles start-up CorWave SA, which developed a left ventricular assist device for treating end-stage heart failure.

Device Week Financing

MDIC Proposes Real-World Evidence Framework For Sponsors To Hasten Product Applications

The document from the Medical Device Innovation Consortium aggregates external data sources, various statistical methods and lays out other considerations for sponsors to help speed up and bolster a premarket product application to the US FDA.

Regulation Research & Development

CMS Extends National Medicare Coverage For Transcatheter Mitral Valve Repair

Medicare now covers transcatheter edge-to-edge repair for both functional and degenerative mitral regurgitation under specific conditions.

Medicare Clinical Trials

DePuy Synthes Gains US FDA Clearance For Velys Robot For Total Knee Surgery

DePuy Synthes expects its Velys robotic-assisted system to be cost-effective, easy-to-use and to be well-suited for use in ambulatory surgery centers.

Orthopedics Approvals

NANS 2021: Nevro’s HF10 Spinal-Cord Stimulator Succeeds In Two Trials

SENZA PDN showed Nevro's HF10 spinal cord stimulation therapy provided sustained relief to patients with painful diabetic neuropathy. Results of a separate trial showed HF10 improved outcomes in patients with non-surgical refractory back pain.

Clinical Trials Market Access

Liquid Biopsy Company Delfi Diagnostics Raised $100M For New Class Of Early Cancer Detection Test

Delfi Diagnostics will use the new funds to expand its team of cancer researchers and machine-learning experts to validate its novel approach for early cancer detection through multiple prospective clinical trials. 

Financing Cancer
UsernamePublicRestriction

Register