Nick Paul Taylor

173 ARTICLES BY Nick Paul Taylor

• Dec. 14, 2018 Medtech industry cheers as NAFTA 2.0 edges forward
• Dec. 13, 2018 FDA adds information on device BLAs to user fee guidance
• Dec. 13, 2018 Grand jury indicts physician over alleged medical testing fraud
• Dec. 13, 2018 FDA rates GE ventilator safety guard recall as Class I event
• Dec. 12, 2018 Australia plans reclassification of medical software to better reflect risk
• Dec. 12, 2018 Merck taps Roche for Keytruda companion diagnostic
• Dec. 11, 2018 Duodenoscope studies find higher-than-expected contamination rate, FDA says
• Dec. 7, 2018 BioSig partners with Mayo Clinic for electrophysiology recording system trial
• Dec. 7, 2018 UPenn surgeons perform first robot-assisted bilateral breast reconstruction
• Dec. 6, 2018 Pear teases top-line data for opioid use digital therapeutic
• Dec. 6, 2018 Edwards expects TAVR demand to fuel double-digit growth in 2019
• Dec. 6, 2018 Subtle Medical gets FDA nod for PET-enhancing algorithm
• Dec. 5, 2018 FDA classifies Medtronic's ventilator correction a Class I recall
• Dec. 5, 2018 OIG finds Medicare overpaid $34M to device suppliers over three years
• Dec. 4, 2018 NIH completes enrollment in huge adolescent neuroimaging study
• Nov. 30, 2018 GE, VA partner to accelerate creation of 3D medical models
• Nov. 30, 2018 Canada vows to strengthen device regulation following media probe
• Nov. 29, 2018 BD, Microsoft create software to identify drug diversion
• Nov. 29, 2018 NIST takes early step toward bringing photonic chips into healthcare
• Nov. 29, 2018 Fighting for market share, LabCorp and Quest plan expansions
• Nov. 28, 2018 Metagenomic sequencing shows promise in diagnosing airway infections
• Nov. 28, 2018 Synaptive recalls system over brain damage risk
• Nov. 27, 2018 FDA approves autoinjector version of Genentech's Actemra
• Nov. 22, 2018 Beckman initiates Class I recall of flow cytometers
• Nov. 22, 2018 FDA device inspections hit high amid overseas oversight push
• Nov. 21, 2018 Sandoz and Pear begin selling digital substance use treatment
• Nov. 20, 2018 Boston Scientific snags BTG for $4.2B
• Nov. 20, 2018 Colfax strikes $3.15B buyout of orthopaedics player DJO
• Nov. 16, 2018 CMS' Verma outlines vision for connected digital health network
• Nov. 16, 2018 Philips report identifies barriers to telehealth uptake
• Nov. 15, 2018 FDA sounds alarm about off-label drug use in pain pumps
• Nov. 15, 2018 ResMed wraps up $750M MatrixCare buyout in SaaS push
• Nov. 15, 2018 US Vascular gets FDA warning letter for long-running problems
• Nov. 14, 2018 Atlantic gains FDA nod for wearable incontinence device
• Nov. 14, 2018 FDA plans to waive informed consent for some clinical trials
• Nov. 14, 2018 Medtronic gets CE mark for low-profile thoracic endograft
• Nov. 13, 2018 Cardiva's vascular closure system cuts patient recovery times in study
• Nov. 13, 2018 Grassley questions FDA about 'troubling' cybersecurity audit
• Nov. 12, 2018 FDA clears battery-powered Ebola test for emergency use
• Nov. 11, 2018 AliveCor's Apple add-on detects afib at similar rate to costly implant
• Nov. 9, 2018 LabCorp loses 2019 Horizon BCBSNJ exclusivity as Quest enters the fray
• Nov. 9, 2018 Monteris modifies brain ablation device to counter safety risk
• Nov. 8, 2018 Rising Cordis costs drag on Cardinal Health profits
• Nov. 8, 2018 BD posts long-awaited clinical data on Lutonix balloon in CLI
• Nov. 8, 2018 Shoulder device sales power Wright to beat-and-raise Q3
• Nov. 7, 2018 FDA shares open source app for collecting real-world data
• Nov. 7, 2018 Disease-detecting AI flounders when applied to images from other hospitals
• Nov. 6, 2018 Abbott, J&J take part in FDA's NEST real world evidence pilot
• Nov. 2, 2018 Patient deaths following Getinge device shutdowns prompt FDA warning
• Nov. 2, 2018 FDA warns about Roche test after reports of patient strokes
• Nov. 1, 2018 Zimmer gets FDA nod for knee implant as portfolio strategy advances
• Nov. 1, 2018 Moody's boosts growth forecast for US medical device industry
• Nov. 1, 2018 23andMe wins FDA clearance for first-of-its-kind genetic test
• Oct. 31, 2018 Baxter posts 'frankly disappointing' sales as hurricane aftereffects linger
• Oct. 31, 2018 HHS opens cybersecurity coordination center after troubled year
• Oct. 30, 2018 Leerink predicts Inspire to clear coverage blockade, quickly grow sleep apnea sales
• Oct. 26, 2018 Speedy Medicare breakthrough device coverage plan slated for March
• Oct. 26, 2018 ResMed posts double-digit growth as software sales soar
• Oct. 25, 2018 Medtronic's dose-controlling app for pain pump gets FDA nod
• Oct. 25, 2018 FDA clears Ansh Labs menopausal status test
• Oct. 25, 2018 Adverse events prompt FDA to advise monitoring of Alcon implants
• Oct. 24, 2018 FDA starts 510(k) pilot to cut optical tomography processing times
• Oct. 24, 2018 Medtronic's low-profile thoracic endograft gets FDA nod
• Oct. 23, 2018 Myriad's BRCA test supports successful ovarian cancer trial
• Oct. 19, 2018 Cardinal credit downgraded after debt-fueled medtech expansion
• Oct. 19, 2018 Viseon gets 510(k) clearance for spinal surgery device
• Oct. 18, 2018 FDA floats changes to cybersecurity guidance to strengthen safeguards
• Oct. 18, 2018 Abbott heart attack test shows early promise in small study
• Oct. 18, 2018 Analysts say AI image analysis market to top $2B by 2023
• Oct. 17, 2018 Immunodiagnostic demand powers Roche Q3 results
• Oct. 16, 2018 Endologix recalls cardiac implants amid ongoing rupture risk
• Oct. 12, 2018 FDA warns of Medtronic device cybersecurity risk
• Oct. 12, 2018 Cardiology volumes seen boosting medtech companies in Q3
• Oct. 11, 2018 Congress expands Sunshine payment reporting rules
• Oct. 11, 2018 ICU Medical taps Imprivata for device cybersecurity support
• Oct. 11, 2018 TAVR volumes dip in Q3 amid 'aggressive surgeon pushback'
• Oct. 10, 2018 Many mastectomy patients later require imaging and biopsies, study finds
• Oct. 10, 2018 Stryker pens deals with Synaptive, Ziehm to boost navigation unit
• Oct. 9, 2018 RadNet buys Medical Arts to expand New York imaging network
• Oct. 5, 2018 Karius posts clinical data on heart infection test
• Oct. 5, 2018 UK recalls 58K pregnancy tests after false positive reports
• Oct. 4, 2018 Survey exposes lack of understanding of EU device regulations
• Oct. 4, 2018 European Parliament passes device-friendly changes to draft HTA law
• Oct. 4, 2018 Regulatory professionals working in devices paid far less than pharma peers
• Oct. 3, 2018 Medical device companies see upside in NAFTA 2.0
• Oct. 3, 2018 US pays 6 times more than Germany for cardiac implants, study finds
• Oct. 2, 2018 FDA starts 510(k) pilot in bid to shorten reviews
• Sept. 28, 2018 FDA floats changes to Special 510(k) program
• Sept. 28, 2018 Butterfly raises $250M in bid to upend ultrasound market
• Sept. 27, 2018 FDA reopens comments on decade-old stent guidance
• Sept. 27, 2018 FDA reclassifies female condoms to reduce regulatory burden
• Sept. 27, 2018 FDA expands use of Baxter bone graft to spinal fusion
• Sept. 26, 2018 Premier gets FDA clearance for saliva-based opioid tests
• Sept. 26, 2018 Venus to buy Keystone, moving into Boston Sci's TAVR turf
• Sept. 25, 2018 FDA approves Cook PAD stent as competition heats up
• Sept. 21, 2018 US wins kickback case against clinical lab Calloway
• Sept. 21, 2018 Medtronic strikes $1.6B takeover of Mazor Robotics
• Sept. 20, 2018 FDA says Florence unlikely to cause critical device shortages
• Sept. 20, 2018 Heparin device guidance to cut overdose risk finalized
• Sept. 20, 2018 BioSig uplists to small-cap Nasdaq exchange amid cardiac device push
• Sept. 19, 2018 MYnd gets breakthrough tag for mental health decision support tool
• Sept. 19, 2018 Trimedx to buy Aramark unit in $300M health tech merger
• Sept. 18, 2018 Device lobby backs FDA combo product GMP plan
• Sept. 14, 2018 AngioDynamics to buy RadiaDyne for radiotherapy devices
• Sept. 14, 2018 FDA softens voluntary consensus guidance after industry slams 'devastating' draft
• Sept. 13, 2018 House passes bill to amend local Medicare coverage decisions
• Sept. 13, 2018 FDA moves to single electronic filings for device submissions
• Sept. 13, 2018 J&J buys EIT for 3D-printed titanium spinal implants
• Sept. 12, 2018 Medtronic plants hit with FDA warning letters
• Sept. 12, 2018 Cook resolves FDA warning letter that slammed quality processes
• Sept. 11, 2018 Brigham and Women's installs first neonatal MRI in US
• Sept. 7, 2018 Boston Scientific inks $600M Augmenix buyout
• Sept. 7, 2018 NIH imaging and bioengineering unit names Bruce Tromberg as director
• Sept. 6, 2018 MRI-compatible cardiac rhythm implants cost hospitals $400M a year: report
• Sept. 6, 2018 Lilly's tau PET tracer hits goals in late-phase trial
• Sept. 6, 2018 Watchdog slams Veterans Health Administration on device sterility
• Sept. 5, 2018 FDA adds 1.6M hours to estimate of device labeling burden
• Sept. 5, 2018 Aetna to cover Abbott's non-opioid pain implant Proclaim
• Sept. 4, 2018 UK sketches medtech future under no Brexit deal
• Aug. 30, 2018 NIH awards $3.8M to test fMRI and suicidal thinking
• Aug. 30, 2018 Alcon withdraws glaucoma device amid long-term safety concerns
• Aug. 30, 2018 Gottlieb hails early breakthrough device successes, plans AI benchmarks
• Aug. 29, 2018 NIH-backed trial links device to drop in cardiac arrest deaths
• Aug. 29, 2018 IDx publishes AI test data that supported landmark approval
• Aug. 28, 2018 Wright Medical inks $435M takeover of implant firm Cartiva
• Aug. 24, 2018 HHS calls for feedback on criteria for EHR reporting program
• Aug. 24, 2018 Dthera gets FDA breakthrough device status for Alzheimer's digital therapeutic
• Aug. 23, 2018 Philips rolls out cardiovascular ultrasound system
• Aug. 23, 2018 FDA posts guidance on endpoints in osteoarthritis trials
• Aug. 23, 2018 Gynesonics gets FDA nod for fibroid ablation device
• Aug. 22, 2018 Australia starts accepting FDA reports in device filings
• Aug. 22, 2018 Merck relaunches diabetes management app as map4health
• Aug. 21, 2018 Facebook, NYU team up to use AI to accelerate MRI scans
• Aug. 17, 2018 FDA details export certificate appeal process in draft guidance
• Aug. 17, 2018 FDA OKs quarterly reporting of device malfunction summaries
• Aug. 16, 2018 AngioDynamics buys biopsy sealant technology from Surgical Specialties
• Aug. 16, 2018 Aetna International pitches vision for interoperable health platform
• Aug. 16, 2018 Medtronic starts selling drug-coated balloon in Japan
• Aug. 15, 2018 AdvaMed pushes back against FDA humanitarian device guidance
• Aug. 15, 2018 With Mylan reeling, Kaléo touts its EpiPen rival for back-to-school season
• Aug. 14, 2018 FDA sets out vision to use real-world data in product evaluations
• Aug. 10, 2018 TGA seeks industry input on cybersecurity, medtech software guidance
• Aug. 10, 2018 Medtronic releases gamification program to improve diabetes outcomes
• Aug. 9, 2018 Analysts question mental health app sector's employer-focused strategy
• Aug. 9, 2018 FDA warns overreliance on membrane tests could up fetal death risk
• Aug. 9, 2018 Boston Scientific inks Veniti takeover to access untapped stent market
• Aug. 8, 2018 Regs, patient perceptions threaten to throttle neuromodulation growth
• Aug. 8, 2018 Boston Children's expands sequencing of patients with epilepsy, IBD
• Aug. 7, 2018 UK regulators reassure medtech sector about Brexit impact
• Aug. 3, 2018 BD raises 2018 targets after broad-based Q3 growth
• Aug. 3, 2018 Bio-Techne closes $250M Exosome Diagnostics takeover
• Aug. 2, 2018 Hologic buys Faxitron for $85M to expand breast cancer business
• Aug. 2, 2018 Baxter gets CE mark for Evo IQ smart infusion pump
• Aug. 2, 2018 Siemens Healthineers hits Q3 goals as imaging sales rise
• Aug. 1, 2018 Currency hit wipes out growth at Fresenius' dialysis device unit
• Aug. 1, 2018 Microsoft files patent for eyeglasses-based blood pressure monitor
• July 31, 2018 MedTech Europe seeks 'urgent' changes to EU regs deadlines
• July 25, 2018 Boston Scientific beats Q2 targets as neuromodulation devices gain share
• July 24, 2018 Sanofi Ventures leads $17M Click round to enter digital therapeutics
• July 20, 2018 US, China power GE Healthcare to double-digit profit rise
• July 19, 2018 LabCorp shuts down IT system after possible hack attack
• July 19, 2018 FDA finalizes guidance on use of EHRs in clinical trials
• July 19, 2018 Abbott beats expectations as sales of diabetes device soar
• July 18, 2018 Ra files for $86M IPO to commercialize vascular disease device
• July 18, 2018 FDA approves Stryker flow diverter, creating competition for Medtronic
• July 13, 2018 Medtronic gets expanded FDA label for cardiac pacing lead
• July 13, 2018 Medtech spared as US unveils tariffs on imports worth $200B
• July 12, 2018 EndoGastric Solutions raises $31M to commercialize reflux device
• July 12, 2018 Feds pump $24M into development of at-home flu tests
• July 12, 2018 Medtronic gets FDA approval for less-invasive LVAD
• July 11, 2018 New body to improve patient EHR matching advised by experts
• July 11, 2018 Wearable ECG patch increases atrial fibrillation diagnosis in clinical trial
• July 10, 2018 US imposes 25% tax on $836M in Chinese medtech imports