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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.

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.

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.

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.
Spotlight On JPM 2021
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.
JPM 2021: Intuitive Surgical, Accelerate Diagnostics, Siemens Healthineers, Exact Sciences, Renalytix
JPM 2021: Boston Scientific, Abbott, Dexcom, Insulet, Silk Road Medical
JPM 2021: Medtronic, Biogen, Edwards LifeSciences, Guardant Health, Illumina
JPM 2021: EY Says Pandemic Leaves Medtech With $500Bn In M&A Firepower

Regulatory Science Tools For Phantoms, Lab Methods Added To US FDA Catalog
The regulatory tools are for use in medical device development.

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.

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.
Latest News
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...
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Policy & Regulation Explore this Topic
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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.

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.
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.
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.
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.
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.
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.
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.
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.
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 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.
OUTLOOK 2021 IS LIVE
Access In Vivo’s annual showcase of special features and industry league tables, including Scrip 100
VIEW 2021 RANKINGSCommercial Explore this Topic
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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.
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.
Fines, But No Prison Time For Ex-Acclarent Execs
The sentences are the latest chapter in a long-running off-label marketing case.
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.
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.
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.
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.
Clinical R&D Explore this Topic
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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.
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.
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.
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.
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.
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.
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.
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