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Compare And Contrast: New UKCA Marking System Will Stress Safety, Quality And Agility
How UK and EU device regulations will differ in 2021, UK approved bodies and Northern Ireland's unfettered access to the UK market were key themes at the ABHI’s annual regulatory conference.
Becton Dickinson Expands Pre-Fillable Syringe Capacity, Anticipating Demand Surge
The company will invest $1.2bn over the next four years to expand and upgrade its manufacturing capacity for pre-fillable syringes and advanced drug delivery systems across seven manufacturing facilities.
Public Health Threat For EU Patients If IVDR Implementation Issues Remain Unaddressed
The IVDR implementation schedule is problematic. European notified bodies say solutions must be grasped if public health is not to suffer.
FDA Will Fire Off Noncompliance Letters To Firms That Don’t Report Device Shortages, Agency Warns
The US agency says in the latest update to its medical device shortages guidance doc that it’ll send enforcement missives to companies that don’t notify the agency of a “permanent discontinuance or an interruption in manufacturing” of products deemed critical during the COVID-19 pandemic.
Spotlight On R&D
FDA Releases COVID-19 Test Performance Data
The data compares the sensitivity of almost 200 diagnostics against a standardized set of samples.
Molecular Dx Company Biocartis ‘At Inflection Point’ As It Eyes Infectious Disease Market
COVID-19: Could Lateral Flow Test Using Glycan Recognition Be A Rapid Testing Breakthrough?
Varian Launches Trial Of Flash Ultra-High Dose Radiotherapy
GT Medical Technologies Raises $16M To Expand Brain Tumor Therapy
CMS Cements In Place Permanent Telehealth Reimbursements In Final Physician Pay Rule
Beneficiaries in nursing homes and in rural areas will benefit from a telehealth expansion in the final CMS physician fee schedule rule.
EU Regulatory Roundup, November 2020: Plenty Of Advice And Guidance As Deadlines Approach
Those marketing products covered under the EU’s MDR and IVD Regulations have plenty of reading this month to help them prepare. More details have also emerged about the UK’s regulatory future.
Warning Letter Close-Outs – November 2020
The US Food and Drug Administration posted two device-related closeout letters in November.
Infographic: COPD Market To Reach $23.7Bn By 2022
The market for devices to treat chronic obstructive pulmonary disease (COPD) is set to grow by 5.0% annually i...
Latest News
Device Week Podcast
Discussed in this episode:
Boston Scientific Gives Up On Lotus Edge TAVR
The company is recalling all unused Lotus Edge inventory and will stop developing the Lotus platform while shifting resources to support its Acurate n...
Data Trackers
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SUNSET Draft Rule Is Trump Admin’s ‘Latest Attempt To Sabotage HHS Programs,’ Analyst Charges
The proposed rule from the US HHS that would require its agencies to review all regulations every 10 years could distract an incoming Biden administration from the COVID-19 pandemic and will “wreak havoc” on Medicare, a senior policy analyst for the Center on Budget and Policy Priorities says.
First-Of-Its-Kind Prostate Cancer Imaging Agent Approved By FDA
Gallium has been approved as a diagnostic agent by the US agency to help early detection of prostate cancer spread in patients who qualify for treatment with surgery or radiation therapy.
Latest From Policy & Regulation
FDA Releases COVID-19 Test Performance Data
The data compares the sensitivity of almost 200 diagnostics against a standardized set of samples.
GAO/NAS Report On AI In Health Care Critical Of FDA Slowness On SaMD Rulemaking
A joint report by the US Government Accountability Office and the National Academy of Sciences slams the FDA for dawdling on final software as a medical device rules.
Global Medtech Guidance Tracker: November 2020
Stay current on regulatory guidelines from around the world with Medtech Insight's Guidance Tracker. Twenty-four guidance documents have been posted on the tracker since its last update.
Warning Letter Roundup & Recap – 1 December 2020
In the only device-related warning letter released by the US FDA this week, Avazo Healthcare was selling two COVID-19 antigen tests without approval, clearance or authorization from the agency.
On-Site Inspections Of US Device Makers Plummet 93% As FDA Scrambles For Virtual Solutions
A sharp decline in the number of in-person facility inspections has forced the FDA to consider creative techniques for remotely evaluating manufacturer compliance during the COVID-19 pandemic. This and other stories topped our list of most-read Medtech Insight articles in November.
EU Notified Bodies Demand IVDR System Readiness Or Deadline Review By Year End
If the tools are not in place by the end of 2020 to allow diagnostics companies to comply with the EU IVDR, the 2022 compliance deadline should be delayed, say EU notified bodies.
Quality Control & Compliance Explore this Topic
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Battery Failures From Improper Cleaning Lead To Class I Recall For Baxter Infusion Pumps
Baxter has recalled more than half a million infusion pumps due to concerns improper cleaning could cause their batteries to malfunction. The recall was designated as high-risk class I by the US FDA.
Warning Letter Roundup & Recap – 1 December 2020
In the only device-related warning letter released by the US FDA this week, Avazo Healthcare was selling two COVID-19 antigen tests without approval, clearance or authorization from the agency.
On-Site Inspections Of US Device Makers Plummet 93% As FDA Scrambles For Virtual Solutions
A sharp decline in the number of in-person facility inspections has forced the FDA to consider creative techniques for remotely evaluating manufacturer compliance during the COVID-19 pandemic. This and other stories topped our list of most-read Medtech Insight articles in November.
Commercial Explore this Topic
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Former MiMedX Execs Convicted On Securities Fraud Charges
The C-suite leaders schemed to falsely record shipments of unwanted products to distributors as sales so the company could meet revenue projections, the government charged.
Latest From Commercial
Zimmer Biomet Buys Sternal Closure Company A&E Medical
The $250m deal adds A&E Medical’s sternal sutures, cable systems, and rigid fixation systems to Zimmer Biomet’s Dental, Spine & Craniomaxillofacial and Thoracic business.
Boston Scientific Divests Specialty Pharma Business
The $800m sale of BTG Specialty Pharmaceuticals business to SERB leaves Boston Scientific with BTG’s successful interventional oncology and vascular products.
Market Brief: Tissue-Engineered Wound Care Market Expected To Reach $1.9Bn By 2024 Amid Rising Chronic Disease
The skin replacement market is led by three key players who have all been impacted by COVID-19, but the sector may see a quicker rebound than others as treatments cannot be deferred for a long time.
APACMed 2020: Healthineers Evolves Therapy Remit And Makes All Asia An Equal Priority
Siemens Healthineers' product mix of diagnostics and imaging products meant it was in the middle of a very dynamic situation when COVID-19 struck.
Execs On The Move: New CEO For Humacyte; Internal Moves At Trinity Biotech, CVRx, Oventus Medical And Cancer Genetics
Trinity Biotech's new CFO is an internal move; Humacyte replaces CEO; chief strategy officer role for former CVRx CFO; and more.
GT Medical Technologies Raises $16M To Expand Brain Tumor Therapy
The company will use the proceeds to fund clinical trials, expand commercialization of its targeted radiation therapy, and file for CE marking in Europe.
Clinical R&D Explore this Topic
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Butterfly Network’s CEO Sees Blank Check Deal As Path To ‘Democratize’ Portable Imaging Platform
Butterfly Network chose SPAC route with Longview Acquisition Corp. to scale its business and expand into the home market in 2021.
Latest From Research & Development
FDA Releases COVID-19 Test Performance Data
The data compares the sensitivity of almost 200 diagnostics against a standardized set of samples.
Molecular Dx Company Biocartis ‘At Inflection Point’ As It Eyes Infectious Disease Market
Belgian developer of cancer diagnostics is building an infectious disease portfolio on the back of its new SARS-CoV-2 test and collaborations with Immunexpress and Endpoint Health.
Market Brief: Tissue-Engineered Wound Care Market Expected To Reach $1.9Bn By 2024 Amid Rising Chronic Disease
The skin replacement market is led by three key players who have all been impacted by COVID-19, but the sector may see a quicker rebound than others as treatments cannot be deferred for a long time.
COVID-19: Could Lateral Flow Test Using Glycan Recognition Be A Rapid Testing Breakthrough?
UK start up Iceni Diagnostics has secured funding to develop its test for the live, intact SARS-CoV-2 virus and the UK government is evaluating a lateral flow device based on the technology for testing saliva samples as part of efforts to step up rapid testing in the country.
GT Medical Technologies Raises $16M To Expand Brain Tumor Therapy
The company will use the proceeds to fund clinical trials, expand commercialization of its targeted radiation therapy, and file for CE marking in Europe.
AMS Acquires Raleigh Adhesive Coatings For £22M To Expand Wound-Care Biz
Advanced Medical Solutions said it will buy Raleigh Adhesive Coatings for £22m in cash to bring silicone coating technology in-house.
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