Susan Kelly

221 ARTICLES BY Susan Kelly

• Feb. 19, 2019 FDA proposes new channel for giving feedback on inspections
• Feb. 19, 2019 FDA clarifies pathway for devices used in regenerative medicine
• Feb. 19, 2019 Medtronic recalls pacemakers due to software error
• Feb. 15, 2019 FDA orders doctor to stop marketing unapproved breast augmentation device
• Feb. 13, 2019 Breast implants face increased safety scrutiny in Canada
• Feb. 13, 2019 Edwards Lifesciences buys maker of brain oxygen monitor
• Feb. 12, 2019 Rapid test for brain injury gets FDA breakthrough status
• Feb. 12, 2019 Device to prevent spinal disc herniation wins PMA after setback
• Feb. 11, 2019 Device that extracts brain tumors gains FDA breakthrough status
• Feb. 11, 2019 FDA finalizes guidance to strengthen its recall processes
• Feb. 11, 2019 Mayo, Intermountain set partnerships for new tech hubs
• Feb. 6, 2019 Teleflex granted FDA approval for vascular closure device
• Feb. 5, 2019 BD results largely expected, beats on revenue
• Feb. 5, 2019 Healthcare groups urge CMS to keep coverage of NGS cancer tests
• Feb. 5, 2019 Cook Medical aortic dissection device gets FDA approval
• Feb. 4, 2019 Oxipit AI-based tool for chest X-ray analysis gets CE mark
• Feb. 4, 2019 FDA announces warfarin test strips, IV fluid transfer systems recalls
• Feb. 4, 2019 Stryker issues voluntary field action after 6 deaths linked to defibrillator bug
• Feb. 1, 2019 Edwards' sales on track, but outlook cautious
• Jan. 30, 2019 Cybersecurity device plan seeks alignment of industry, regulators
• Jan. 30, 2019 Stryker impresses in Q4, sets bold forecasts
• Jan. 29, 2019 J&J data suggests its stapler reduces more lung surgery air leaks than competitor
• Jan. 29, 2019 FDA sets March date for breast implant panel meeting
• Jan. 28, 2019 Draeger Medical recalls single-use breathing circuits
• Jan. 28, 2019 ResMed Q2 revenue miss sends shares plunging
• Jan. 28, 2019 Zimmer Biomet gets 510(k) for robotic knee surgery system
• Jan. 25, 2019 Intuitive Surgical to step up investment outside the US
• Jan. 23, 2019 Medtronic data show no paclitaxel-mortality link amid FDA warnings
• Jan. 23, 2019 Illumina TruSight assay gets FDA breakthrough designation
• Jan. 22, 2019 M&A, robotics among medtech growth drivers for 2019: Moody's
• Jan. 22, 2019 Verily Study Watch gets FDA nod for EKG
• Jan. 22, 2019 Bigfoot could shake up insulin delivery market, analyst says
• Jan. 18, 2019 FDA flags mortality risk of paclitaxel with stents, balloons for PAD
• Jan. 16, 2019 FDA clears energy tools for TransEnterix robotic surgery system
• Jan. 16, 2019 Medtronic links patients' pacemakers with their smartphones
• Jan. 15, 2019 Abbott heart device for premature babies wins FDA approval
• Jan. 15, 2019 FDA clears absorbable foot and ankle implant
• Jan. 14, 2019 Jefferies predicts upbeat 2019 medtech outlook
• Jan. 14, 2019 Mobile and wearable data increasingly useful to patients, JAMA authors say
• Jan. 14, 2019 FDA grants breakthrough designation to wearable dialysis device
• Jan. 11, 2019 FDA to beef up Sentinel postmarket electronic safety system
• Jan. 9, 2019 Medical records key to Apple health strategy: report
• Jan. 9, 2019 Medtronic recalls imaging software used in brain surgery
• Jan. 8, 2019 Hologic boosts its first-quarter revenue outlook
• Jan. 8, 2019 TransEnterix forecasts revenue growth, sells more robots
• Jan. 7, 2019 Endologix recalls Nellix aneurysm sealing system
• Jan. 7, 2019 AI with EKG can detect a form of heart disease, research shows
• Jan. 7, 2019 Hospitals gain leverage on medical device pricing: report
• Jan. 4, 2019 LabCorp inks licensing pact for Genfit liver test
• Dec. 31, 2018 CMS sets user fee increase for CLIA-certified labs
• Dec. 26, 2018 GAO: DME supplier pool shrinks under competitive bidding
• Dec. 21, 2018 Health Canada unveils plan to improve medical device safety
• Dec. 20, 2018 UK regulator puts brakes on Thermo Fisher-Gatan deal
• Dec. 19, 2018 Aortic stent graft market on path to solid growth
• Dec. 19, 2018 Cardiva wins FDA approval for its vascular closure system
• Dec. 18, 2018 Medtronic wins FDA OK for InterStim smart programmer
• Dec. 18, 2018 OIG: Medicare contractor overpaid hospitals for radiation treatments
• Dec. 17, 2018 FDA addresses manufacturing site changes in final guidance
• Dec. 17, 2018 FDA draft guidance aims to clarify X-ray radiation rules
• Dec. 17, 2018 Nonprofit gets boost to realize automated insulin delivery app
• Dec. 14, 2018 Rapid diagnostic test detects Ebola, malaria in the field
• Dec. 12, 2018 UK readies 'worst-case' Brexit plan for medical devices
• Dec. 12, 2018 HIMSS: Health coaching could boost value of wearables
• Dec. 11, 2018 Thermo Fisher gets FDA nod for plazomicin immunoassay
• Dec. 11, 2018 Hologic begins selling 3-in-1 uterine scope
• Dec. 10, 2018 Cybersecurity priorities laid out by key House panel
• Dec. 10, 2018 FDA clears Contego Medical peripheral angioplasty system
• Dec. 10, 2018 FDA to revisit transvaginal mesh issues at February meeting
• Dec. 7, 2018 Device industry 2019 outlook beats hospitals, pharma: Moody's
• Dec. 5, 2018 ResMed buys maker of COPD, asthma monitoring platform
• Dec. 5, 2018 FDA endorses open database for genetic variants
• Dec. 4, 2018 Medtronic AFib study combines hot, cold ablation techniques
• Dec. 4, 2018 Medtech R&D adapting under new pressures, industry study shows
• Dec. 3, 2018 Medicare could overpay billions for lab tests: GAO
• Dec. 3, 2018 FDA OKs first test to detect herpes in newborns
• Dec. 3, 2018 LabCorp cuts its profit outlook, citing volume shortfall
• Nov. 30, 2018 FDA issues draft guidance on blood glucose monitors
• Nov. 28, 2018 Zimmer Biomet recalls spine fusion, bone growth stimulators
• Nov. 28, 2018 Quest closes buy of Midwest lab services business
• Nov. 27, 2018 Reprocessor receives FDA clearance for 4 catheters
• Nov. 27, 2018 Pacing leads recalled for potential connector separation
• Nov. 26, 2018 Medtronic buys nutrition data startup for diabetes care
• Nov. 21, 2018 FDA details ramp-up of postmarket device oversight
• Nov. 21, 2018 Scientists unveil first 3D images from new whole-body scanner
• Nov. 20, 2018 Medtronic posts strong Q2 on diabetes, pain management
• Nov. 20, 2018 New Philips ventilator combines two modes in one device
• Nov. 20, 2018 FDA plan would ease regulations for prescription drug apps
• Nov. 19, 2018 Edwards Lifesciences gets CE mark for advanced heart valve
• Nov. 19, 2018 Medtronic aneurysm repair device proves durable in complex cases
• Nov. 19, 2018 Boston Scientific to spend over $200M in restructuring
• Nov. 16, 2018 GE Healthcare recalls nuclear medicine imaging systems
• Nov. 9, 2018 Owens & Minor names interim chairman and CEO
• Nov. 7, 2018 Long-term data backs Medtronic drug-coated balloon for PAD
• Nov. 7, 2018 FDA clears Siemens Healthineers mobile 3D imaging arm
• Nov. 6, 2018 Becton Dickinson Q4 revenue up, some Wall Street misses
• Nov. 5, 2018 FDA approves 2 devices to aid in thyroid surgery
• Nov. 5, 2018 Pact to rush medical products for military clinched
• Nov. 5, 2018 FDA extends time to comply on unique device identification
• Nov. 2, 2018 FDA deficient on device cybersecurity readiness, watchdog says
• Oct. 31, 2018 NuVasive CEO says spine industry poised to consolidate
• Oct. 30, 2018 Baxter earns CE mark for new renal replacement system
• Oct. 30, 2018 Genentech releases more data on refillable eye implant
• Oct. 29, 2018 FDA panel to review first-of-a-kind heart failure device
• Oct. 29, 2018 Philips launches all-in-one breast ultrasound product
• Oct. 29, 2018 Drug-delivery device developer snags Sanofi as investor
• Oct. 26, 2018 Stryker touts benefits of Mako robot on knee outcomes, costs
• Oct. 24, 2018 Edwards Lifesciences Q3 sales up 10%
• Oct. 23, 2018 Quest disappoints with full year revenue forecast cut
• Oct. 22, 2018 Heater-cooler device redesigned to limit infections: FDA
• Oct. 22, 2018 Abbott HeartMate 3 gets OK as transplant alternative
• Oct. 22, 2018 Stryker asks to extend anti-trust deadline for K2M deal
• Oct. 19, 2018 Intuitive Surgical sees 20% growth in da Vinci robot use
• Oct. 17, 2018 FDA clears Pfizer PARP drug, Myriad companion test for breast cancer
• Oct. 17, 2018 Medtronic sells workflow tool to boost its opioid pump
• Oct. 16, 2018 J&J posts softer Q3 device sales
• Oct. 15, 2018 Health apps require robust regulatory approach: JAMA opinion
• Oct. 15, 2018 CT scans can diagnose complex heart disease, study shows
• Oct. 15, 2018 FDA to fund pediatric medical device consortium
• Oct. 12, 2018 TransEnterix wins FDA nod for smaller robotic instruments
• Oct. 12, 2018 FDA OKs DNA-based test for blood transfusion compatibility
• Oct. 10, 2018 RightEye's eye-tracking system gets FDA clearance
• Oct. 10, 2018 Siemens' latest 1.5T MRI scanner gets FDA nod
• Oct. 9, 2018 Researchers develop biodegradable nerve stimulation device
• Oct. 9, 2018 Eximo Medical gains FDA clearance for atherectomy laser
• Oct. 8, 2018 1 in 5 health IT execs say malware has hit devices
• Oct. 8, 2018 Bose self-fitting hearing aid gets FDA approval
• Oct. 8, 2018 Prostate cancer imaging agent meets one of two study endpoints
• Oct. 5, 2018 Fitbit rolling out Charge 3 with focus on sleep tracking
• Oct. 3, 2018 Baxter, Mayo team up on outpatient kidney care center
• Oct. 3, 2018 Artificial pancreas has edge over insulin pump therapy in study
• Oct. 2, 2018 Stryker settles foreign corrupt practice charges, makes small acquisition
• Oct. 2, 2018 FDA, ECRI, device group keep up drumbeat on cybersecurity risks
• Oct. 1, 2018 FDA finds fault with some insulin pen use directions
• Oct. 1, 2018 Doctor survey finds strong interest in new urology devices
• Oct. 1, 2018 FDA clears NGS test to detect residual blood cancer cells
• Sept. 28, 2018 Hologic acquires developer of breast cancer surgery marker
• Sept. 26, 2018 Global device industry set to grow 5.6% a year through 2024: report
• Sept. 26, 2018 Medtronic launches Infinity spine fusion system
• Sept. 25, 2018 Medtronic CoreValve proves durable in longer-term data
• Sept. 25, 2018 FDA gives final guidance on device benefits, risks in 510(k) submissions
• Sept. 24, 2018 Boston Scientific's Eluvia wins FDA nod, seen as effective as Cook's Zilver in study
• Sept. 24, 2018 Medtronic heart stent works as well as thin-strut Orsiro: study
• Sept. 24, 2018 Abbott's MitraClip keeps more heart valve patients alive in study
• Sept. 21, 2018 Medicare lab test spending up slightly in 2017: OIG
• Sept. 19, 2018 Medtronic to study TAVR in low-risk bicuspid patients
• Sept. 19, 2018 Ra Medical amends IPO plan
• Sept. 18, 2018 AI can identify lung cancer types in images, study finds
• Sept. 18, 2018 NIH funds study of artery imaging without contrast dyes
• Sept. 17, 2018 Stent to seal coronary artery perforations gets FDA nod
• Sept. 17, 2018 FDA defends its work on breast implant safety
• Sept. 17, 2018 FDA tests new way to shorten 510(k) review times
• Sept. 14, 2018 Gottlieb: FDA pursuing faster approval path for diagnostics
• Sept. 12, 2018 FDA advised to step up device cybersecurity checks premarket
• Sept. 12, 2018 Companion diagnostic for bile duct cancer treatment in works
• Sept. 11, 2018 A call to make EHRs safer for pediatric patients
• Sept. 11, 2018 Medtronic to study one month of DAPT in high-bleeding-risk patients
• Sept. 10, 2018 FDA raises concerns about feeding tube misconnections
• Sept. 10, 2018 Becton Dickinson sells bioprocessing business to Thermo Fisher
• Sept. 10, 2018 Bundled payment model cuts joint replacement costs in study
• Sept. 7, 2018 FDA clears new version of Baxter bone graft substitute
• Sept. 7, 2018 Livongo adds continuous glucose data via Abbott's FreeStyle Libre
• Sept. 5, 2018 Developing afib after valve implant raises risks, study finds
• Sept. 5, 2018 Cigna names chief data and analytics officer
• Sept. 4, 2018 Otsuka rolls out Abilify digital pill through Magellan network
• Sept. 4, 2018 European Society of Cardiology endorses iFR in guidelines
• Aug. 31, 2018 Stryker buys spine device maker K2M for $1.4B
• Aug. 31, 2018 Medtronic cryoballoon reduces persistent afib symptoms in study
• Aug. 29, 2018 SynCardia stands behind its artificial heart driver
• Aug. 29, 2018 Balloons as effective as stents to open small arteries, study says
• Aug. 28, 2018 FDA warns Zimmer Biomet about quality violations at Indiana plant
• Aug. 28, 2018 Medication reminder apps for heart patients could save lives, study says
• Aug. 27, 2018 DexCom acquires maker of insulin dosing algorithm
• Aug. 27, 2018 Patients getting needed supplies under DME bidding: GAO
• Aug. 27, 2018 Hands-free device may track astronauts' vital signs in space
• Aug. 24, 2018 Robotic surgery market is about to get crowded, report says
• Aug. 22, 2018 FDA approves Keytruda companion test for bladder cancer
• Aug. 22, 2018 NIST offers guide to securing wireless infusion pumps
• Aug. 21, 2018 Diabetes, heart device sales drive strong Medtronic Q1
• Aug. 20, 2018 FDA finds higher death, stroke rates for latest SynCardia artificial heart driver
• Aug. 20, 2018 Noninvasive magnetic stimulation for OCD wins FDA nod
• Aug. 20, 2018 Doctors often fail to list conflicts in device studies: JAMA report
• Aug. 17, 2018 Early A1C test may reduce gestational diabetes risk: NIH study
• Aug. 15, 2018 Maryland failed to secure its Medicaid data: OIG
• Aug. 15, 2018 Healthix switching software vendors for patient matching
• Aug. 14, 2018 BARDA, J&J team to crowdsource respiratory device ideas
• Aug. 14, 2018 FDA approves one-year contraceptive ring
• Aug. 13, 2018 NuVasive, Siemens partner on spine surgery imaging
• Aug. 13, 2018 Most recalled foot, ankle devices are 501(k) approved, study finds
• Aug. 13, 2018 FDA OKs marketing of contraceptive app
• Aug. 10, 2018 Burn treatment earns expanded compassionate use approval
• Aug. 10, 2018 Medtronic begins study of ICD with leads outside the heart
• Aug. 8, 2018 Senseonics rolls out 90-day continuous glucose monitoring
• Aug. 8, 2018 MDLive, Beacon partner on virtual behavioral health visits
• Aug. 7, 2018 New blood test can rule out heart attack faster
• Aug. 7, 2018 Varian acquires maker of patient monitoring system
• Aug. 6, 2018 Cardinal Health posts Q4 loss as Cordis struggles
• Aug. 6, 2018 FCC seeks comments on $100M telehealth pilot
• Aug. 3, 2018 Abbott device to treat Parkinson's now MRI-compatible
• Aug. 1, 2018 FDA approves Medtronic implant for rare form of hypertension
• Aug. 1, 2018 CSI, Aerolase partner on laser atherectomy device
• July 31, 2018 FDA warns about vaginal 'rejuvenation' device claims
• July 30, 2018 FDA approves Abbott's blood sugar sensor for 14-day use
• July 30, 2018 FDA sets 2019 medical device user fee rates
• July 30, 2018 CMS advisers split on procedure volume rules for TAVR
• July 30, 2018 CMS pitches covering cardiac catheterization at surgical centers
• July 27, 2018 FDA gives draft guidance on atherectomy device submissions
• July 25, 2018 Stryker says Q2 tops goals, will stick to M&A playbook
• July 24, 2018 Quest Diagnostics posts slight Q2 revenue miss
• July 23, 2018 Bayer to stop selling Essure birth control implant in US
• July 23, 2018 NIH center makes public a trove of CT images for research
• July 23, 2018 Tendyne investors sue Abbott over lost milestone payment
• July 20, 2018 Intuitive Surgical profit up on strong da Vinci robot sales
• July 18, 2018 FDA reiterates concern about off-label use of bile-duct stents
• July 18, 2018 Calls to revamp physician self-referral law grow louder
• July 17, 2018 Device industry lobbies FDA on combo product classification
• July 17, 2018 J&J says medical device sales improve in second quarter
• July 16, 2018 Abbott device to repair leaky heart valves approved
• July 16, 2018 CMS targets data gaps in setting lab payments
• July 11, 2018 Stryker names new president, tweaks leadership structure
• July 11, 2018 Medtronic, UnitedHealthcare say value-based pact cut diabetes costs
• July 10, 2018 Better cybersecurity safeguards urged for medical devices, EHRs