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Featured Stories

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

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

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.

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

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 Coronavirus COVID-19

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 Manufacturing

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

Device Week Podcast




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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 sep...

Clinical Trials Market Access

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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 Coronavirus COVID-19

Canada Boosts Postmarket Device Safety With New Reporting Rules

Device companies operating in Canada are being advised to review their internal procedures in anticipation of new postmarket requirements that come into force this year.

Canada Guidance Documents Regulation

Latest From Policy & Regulation

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

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

Biden Regulatory Freeze Could Slam Brakes On SUNSET Reg Review Rule From HHS

The tactic aims to allow the new Biden administration to scrutinize so-called “midnight rules” issued in the final days of the Trump administration before they take effect. One reg targeted by the freeze is the recent SUNSET rule from the US HHS, which would require the department and its agencies – including the FDA – to review all regulations every 10 years to determine whether they’re still necessary.

Regulation Policy

UK Government Promise For 2021: No Halting The Advance Of Healthtech Innovation Adoption

There can be no such thing as a COVID dividend, but the renewed digital push and momentum for health system change perhaps come closest.

United Kingdom Policy

International Steam Sterilization Standard Updated By AAMI

ANSI/AAMI ST79:2017 has gained four new amendments, including recommendations and clarifications for “maintaining the integrity” of sterile process areas. The standard is used by health care professionals who use steam to sterilize devices and other medical products.

International Standards

Quality Control & Compliance Explore this Topic

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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

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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 Enforcement

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

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

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

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

Philips Adds Capsule Technologies To Connected Care Business

Philips will pay $635m for the Massachusetts-based developer of a platform that connects medical devices and electronic medical records in hospitals.

M & A Digital Health

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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 Cardiovascular

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

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

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 fund investment. The company is developing a new pulsatile LVAD.

Start-up Spotlight Cardiovascular

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

JPM 2021: Conformis Announces ACS Knee For 2H 2021, Integra Weathers Pandemic

The annual J.P. Morgan Healthcare Conference includes presentations from many major medtech companies outlining their growth strategies and expectations for 2021. Here are some of the highlights from the final day of the meeting.

Orthopedics Financing
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