Susan Kelly

290 articles by Susan Kelly

• FDA pitches stronger controls, new labeling for surgical staplers

  April 24, 2019

• Edwards Lifesciences beats profit forecasts amid low-risk TAVR momentum

  April 24, 2019

• Study supports genetic testing for sudden cardiac arrest

  April 23, 2019

• Obesity device to slow stomach emptying gets approval

  April 23, 2019

• More patients die after starting dialysis than registry suggests: Harvard study

  April 23, 2019

• FDA wants details on nitinol in premarket device applications

  April 22, 2019

• FDA drafts premarket recommendations for quantitative medical imaging

  April 22, 2019

• CDC rule removes barrier to sale of escape respirators

  April 22, 2019

• Brainlab recalls spine 3D navigation software for incorrect display

  April 17, 2019

• AI poised to 'transform' medical imaging, radiology society says

  April 17, 2019

• FDA approves post-angioplasty dissection repair device

  April 16, 2019

• Edible hydrogel capsule to treat obesity gets FDA go-ahead

  April 16, 2019

• Contaminated duodenoscopes linked to 3 new deaths, 45 more infections, FDA says

  April 15, 2019

• FDA flags breathing tube shortage tied to sterilization plant closing

  April 15, 2019

• AliveCor's AI software for EKG rhythms gets market OK

  April 15, 2019

• Avinger's image-guided device for PAD gets FDA nod

  April 11, 2019

• Prices soar for new medtech, but payment lags: report

  April 10, 2019

• Pfizer, Concerto collaborate on AI in precision oncology

  April 10, 2019

• FDA warns patients to steer clear of pre-owned test strips

  April 9, 2019

• Medtronic, Blue Cross strike value-based pact for glucose monitors

  April 9, 2019

• Abiomed reports improved survival rates in cardiogenic shock patients

  April 8, 2019

• Nvidia, American College of Radiology partner on AI platform

  April 8, 2019

• Medtronic analysis tracks reduced strokes in HVAD patients

  April 8, 2019

• Saturated oxygen treatment for heart attack wins FDA approval

  April 5, 2019

• Disposable spinal rod strain sensor earns De Novo clearance

  April 3, 2019

• FDA greenlights study of breakthrough device to treat aggressive pancreatic cancer

  April 3, 2019

• Channel Medsystems' endometrial cryoablation device gets FDA nod

  April 2, 2019

• FDA gives PMA to injection treatment for knee pain

  April 2, 2019

• FDA repeals some regs on radiation-emitting devices

  April 1, 2019

• CMS to tackle lab payments codes in pair of public meetings

  April 1, 2019

• FDA finalizes rules for anthrax bacteria tests, spine devices

  April 1, 2019

• ECRI Institute launching international device testing lab

  March 29, 2019

• Sterilizer plant shutdown prompts FDA action on device shortages

  March 27, 2019

• FDA clears Zimmer robot that combines brain, spine, knee functionality

  March 27, 2019

• Details of LivaNova depression device study finalized

  March 26, 2019

• CMS due to release updated TAVR coverage determination

  March 26, 2019

• Biomagnetic imaging for chest pain wins FDA clearance

  March 25, 2019

• Not even money prods patients to mail-in colon tests, study suggests

  March 25, 2019

• EU device group wants clarity on expert panels under MDR

  March 25, 2019

• FDA approves first-of-its-kind heart failure device

  March 22, 2019

• Alzheimer's device De Novo on the line at FDA panel

  March 20, 2019

• FDA warns Sientra, J&J's Mentor on lax post-approval breast implant studies

  March 20, 2019

• BD wins PMA for stent treating venous occlusive disease

  March 19, 2019

• FDA outlines new device priorities in budget justification report

  March 19, 2019

• FDA: Avoid paclitaxel-coated PAD devices for most patients

  March 18, 2019

• TAVR called 'game changing' in studies of low-risk patients

  March 18, 2019

• Intuitive's da Vinci SP gets FDA otolaryngology clearance

  March 18, 2019

• Abbott gains expanded indication for MitraClip valve repair device

  March 15, 2019

• FDA qualifies test for traumatic brain injury

  March 13, 2019

• Smith & Nephew buys skin substitute maker for $660M

  March 13, 2019

• Intrathecal drug delivery system wins FDA breakthrough designation

  March 12, 2019

• Edwards deepens structural heart position with new investments

  March 12, 2019

• FDA flags surgical stapler risks, plans advisory meeting

  March 11, 2019

• TAVR for low-risk patients in spotlight at ACC

  March 11, 2019

• AdvaMed raises concerns with FDA's proposed De Novo model

  March 11, 2019

• AI tool for cancer diagnosis wins FDA breakthrough status

  March 8, 2019

• Ascension hospital network taps Abbott diagnostics for lab work

  March 6, 2019

• Device to detect internal bleeding wins De Novo clearance

  March 5, 2019

• Masimo brain monitor gets CE mark pediatric indication

  March 5, 2019

• Blood test identifies proteins to predict preterm birth

  March 4, 2019

• Medtronic says corrected IN.PACT analysis to be published in JACC

  March 4, 2019

• Scientists propose universal standard to calibrate CT scanners

  March 4, 2019

• Gene test for antibiotic resistance gets FDA breakthrough nod

  March 1, 2019

• Medtronic Resolute stent gains expanded indication

  Feb. 27, 2019

• Thermo Fisher lung cancer test wins expanded approval in Japan

  Feb. 27, 2019

• FDA warns breast infrared imaging tool should not replace mammography

  Feb. 26, 2019

• Verily launches eye disease screening algorithm in India

  Feb. 26, 2019

• Swiss regulator weighs in on textured breast implants

  Feb. 20, 2019

• Intuitive gains FDA clearance for Ion lung catheter

  Feb. 20, 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. 19, 2019

• FDA orders doctor to stop marketing unapproved breast augmentation device

  Feb. 15, 2019

• Breast implants face increased safety scrutiny in Canada

  Feb. 13, 2019

• Edwards Lifesciences buys maker of brain oxygen monitor

  Feb. 13, 2019

• Rapid test for brain injury gets FDA breakthrough status

  Feb. 12, 2019

• Device to prevent spinal disc herniation wins PMA after setback

  Feb. 12, 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. 11, 2019

• Teleflex granted FDA approval for vascular closure device

  Feb. 6, 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. 5, 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. 4, 2019

• Edwards' sales on track, but outlook cautious

  Feb. 1, 2019

• Cybersecurity device plan seeks alignment of industry, regulators

  Jan. 30, 2019

• Stryker impresses in Q4, sets bold forecasts

  Jan. 30, 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. 29, 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. 28, 2019

• Intuitive Surgical to step up investment outside the US

  Jan. 25, 2019

• Medtronic data show no paclitaxel-mortality link amid FDA warnings

  Jan. 23, 2019

• Illumina TruSight assay gets FDA breakthrough designation

  Jan. 23, 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. 22, 2019

• FDA flags mortality risk of paclitaxel with stents, balloons for PAD

  Jan. 18, 2019

• FDA clears energy tools for TransEnterix robotic surgery system

  Jan. 16, 2019

• Medtronic links patients' pacemakers with their smartphones

  Jan. 16, 2019

• Abbott heart device for premature babies wins FDA approval

  Jan. 15, 2019

• FDA clears absorbable foot and ankle implant

  Jan. 15, 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. 14, 2019

• FDA to beef up Sentinel postmarket electronic safety system

  Jan. 11, 2019

• Medical records key to Apple health strategy: report

  Jan. 9, 2019

• Medtronic recalls imaging software used in brain surgery

  Jan. 9, 2019

• Hologic boosts its first-quarter revenue outlook

  Jan. 8, 2019

• TransEnterix forecasts revenue growth, sells more robots

  Jan. 8, 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. 7, 2019

• LabCorp inks licensing pact for Genfit liver test

  Jan. 4, 2019

• CMS sets user fee increase for CLIA-certified labs

  Dec. 31, 2018

• GAO: DME supplier pool shrinks under competitive bidding

  Dec. 26, 2018

• Health Canada unveils plan to improve medical device safety

  Dec. 21, 2018

• UK regulator puts brakes on Thermo Fisher-Gatan deal

  Dec. 20, 2018

• Aortic stent graft market on path to solid growth

  Dec. 19, 2018

• Cardiva wins FDA approval for its vascular closure system

  Dec. 19, 2018

• Medtronic wins FDA OK for InterStim smart programmer

  Dec. 18, 2018

• OIG: Medicare contractor overpaid hospitals for radiation treatments

  Dec. 18, 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. 17, 2018

• Rapid diagnostic test detects Ebola, malaria in the field

  Dec. 14, 2018

• UK readies 'worst-case' Brexit plan for medical devices

  Dec. 12, 2018

• HIMSS: Health coaching could boost value of wearables

  Dec. 12, 2018

• Thermo Fisher gets FDA nod for plazomicin immunoassay

  Dec. 11, 2018

• Hologic begins selling 3-in-1 uterine scope

  Dec. 11, 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. 10, 2018

• Device industry 2019 outlook beats hospitals, pharma: Moody's

  Dec. 7, 2018

• ResMed buys maker of COPD, asthma monitoring platform

  Dec. 5, 2018

• FDA endorses open database for genetic variants

  Dec. 5, 2018

• Medtronic AFib study combines hot, cold ablation techniques

  Dec. 4, 2018

• Medtech R&D adapting under new pressures, industry study shows

  Dec. 4, 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

  Dec. 3, 2018

• FDA issues draft guidance on blood glucose monitors

  Nov. 30, 2018

• Zimmer Biomet recalls spine fusion, bone growth stimulators

  Nov. 28, 2018

• Quest closes buy of Midwest lab services business

  Nov. 28, 2018

• Reprocessor receives FDA clearance for 4 catheters

  Nov. 27, 2018

• Pacing leads recalled for potential connector separation

  Nov. 27, 2018

• Medtronic buys nutrition data startup for diabetes care

  Nov. 26, 2018

• FDA details ramp-up of postmarket device oversight

  Nov. 21, 2018

• Scientists unveil first 3D images from new whole-body scanner

  Nov. 21, 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. 20, 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. 19, 2018

• GE Healthcare recalls nuclear medicine imaging systems

  Nov. 16, 2018

• Owens & Minor names interim chairman and CEO

  Nov. 9, 2018

• Long-term data backs Medtronic drug-coated balloon for PAD

  Nov. 7, 2018

• FDA clears Siemens Healthineers mobile 3D imaging arm

  Nov. 7, 2018

• Becton Dickinson Q4 revenue up, some Wall Street misses

  Nov. 6, 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. 5, 2018

• FDA deficient on device cybersecurity readiness, watchdog says

  Nov. 2, 2018

• NuVasive CEO says spine industry poised to consolidate

  Oct. 31, 2018

• Baxter earns CE mark for new renal replacement system

  Oct. 30, 2018

• Genentech releases more data on refillable eye implant

  Oct. 30, 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. 29, 2018

• Stryker touts benefits of Mako robot on knee outcomes, costs

  Oct. 26, 2018

• Edwards Lifesciences Q3 sales up 10%

  Oct. 24, 2018

• Quest disappoints with full year revenue forecast cut

  Oct. 23, 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. 22, 2018

• Intuitive Surgical sees 20% growth in da Vinci robot use

  Oct. 19, 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. 17, 2018

• J&J posts softer Q3 device sales

  Oct. 16, 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. 15, 2018

• TransEnterix wins FDA nod for smaller robotic instruments

  Oct. 12, 2018

• FDA OKs DNA-based test for blood transfusion compatibility

  Oct. 12, 2018

• RightEye's eye-tracking system gets FDA clearance

  Oct. 10, 2018

• Siemens' latest 1.5T MRI scanner gets FDA nod

  Oct. 10, 2018

• Researchers develop biodegradable nerve stimulation device

  Oct. 9, 2018

• Eximo Medical gains FDA clearance for atherectomy laser

  Oct. 9, 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. 8, 2018

• Fitbit rolling out Charge 3 with focus on sleep tracking

  Oct. 5, 2018

• Baxter, Mayo team up on outpatient kidney care center

  Oct. 3, 2018

• Artificial pancreas has edge over insulin pump therapy in study

  Oct. 3, 2018

• Stryker settles foreign corrupt practice charges, makes small acquisition

  Oct. 2, 2018

• FDA, ECRI, device group keep up drumbeat on cybersecurity risks

  Oct. 2, 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

  Oct. 1, 2018

• Hologic acquires developer of breast cancer surgery marker

  Sept. 28, 2018

• Global device industry set to grow 5.6% a year through 2024: report

  Sept. 26, 2018

• Medtronic launches Infinity spine fusion system

  Sept. 26, 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. 25, 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. 24, 2018

• Medicare lab test spending up slightly in 2017: OIG

  Sept. 21, 2018

• Medtronic to study TAVR in low-risk bicuspid patients

  Sept. 19, 2018

• Ra Medical amends IPO plan

  Sept. 19, 2018

• AI can identify lung cancer types in images, study finds

  Sept. 18, 2018

• NIH funds study of artery imaging without contrast dyes

  Sept. 18, 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. 17, 2018

• Gottlieb: FDA pursuing faster approval path for diagnostics

  Sept. 14, 2018

• FDA advised to step up device cybersecurity checks premarket

  Sept. 12, 2018

• Companion diagnostic for bile duct cancer treatment in works

  Sept. 12, 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. 11, 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. 10, 2018

• FDA clears new version of Baxter bone graft substitute

  Sept. 7, 2018

• Livongo adds continuous glucose data via Abbott's FreeStyle Libre

  Sept. 7, 2018

• Developing afib after valve implant raises risks, study finds

  Sept. 5, 2018

• Cigna names chief data and analytics officer

  Sept. 5, 2018

• Otsuka rolls out Abilify digital pill through Magellan network

  Sept. 4, 2018

• European Society of Cardiology endorses iFR in guidelines

  Sept. 4, 2018

• Stryker buys spine device maker K2M for $1.4B

  Aug. 31, 2018

• Medtronic cryoballoon reduces persistent afib symptoms in study

  Aug. 31, 2018

• SynCardia stands behind its artificial heart driver

  Aug. 29, 2018

• Balloons as effective as stents to open small arteries, study says

  Aug. 29, 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. 28, 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. 27, 2018

• Robotic surgery market is about to get crowded, report says

  Aug. 24, 2018

• FDA approves Keytruda companion test for bladder cancer

  Aug. 22, 2018

• NIST offers guide to securing wireless infusion pumps

  Aug. 22, 2018

• Diabetes, heart device sales drive strong Medtronic Q1

  Aug. 21, 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. 20, 2018

• Early A1C test may reduce gestational diabetes risk: NIH study

  Aug. 17, 2018

• Maryland failed to secure its Medicaid data: OIG

  Aug. 15, 2018

• Healthix switching software vendors for patient matching

  Aug. 15, 2018

• BARDA, J&J team to crowdsource respiratory device ideas

  Aug. 14, 2018

• FDA approves one-year contraceptive ring

  Aug. 14, 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. 13, 2018

• Burn treatment earns expanded compassionate use approval

  Aug. 10, 2018

• Medtronic begins study of ICD with leads outside the heart

  Aug. 10, 2018

• Senseonics rolls out 90-day continuous glucose monitoring

  Aug. 8, 2018

• MDLive, Beacon partner on virtual behavioral health visits

  Aug. 8, 2018

• New blood test can rule out heart attack faster

  Aug. 7, 2018

• Varian acquires maker of patient monitoring system

  Aug. 7, 2018

• Cardinal Health posts Q4 loss as Cordis struggles

  Aug. 6, 2018

• FCC seeks comments on $100M telehealth pilot

  Aug. 6, 2018

• Abbott device to treat Parkinson's now MRI-compatible

  Aug. 3, 2018

• FDA approves Medtronic implant for rare form of hypertension

  Aug. 1, 2018

• CSI, Aerolase partner on laser atherectomy device

  Aug. 1, 2018

• FDA warns about vaginal 'rejuvenation' device claims

  July 31, 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 30, 2018

• FDA gives draft guidance on atherectomy device submissions

  July 27, 2018

• Stryker says Q2 tops goals, will stick to M&A playbook

  July 25, 2018

• Quest Diagnostics posts slight Q2 revenue miss

  July 24, 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 23, 2018

• Intuitive Surgical profit up on strong da Vinci robot sales

  July 20, 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 18, 2018

• Device industry lobbies FDA on combo product classification

  July 17, 2018

• J&J says medical device sales improve in second quarter

  July 17, 2018

• Abbott device to repair leaky heart valves approved

  July 16, 2018

• CMS targets data gaps in setting lab payments

  July 16, 2018

• Stryker names new president, tweaks leadership structure

  July 11, 2018

• Medtronic, UnitedHealthcare say value-based pact cut diabetes costs

  July 11, 2018

• Better cybersecurity safeguards urged for medical devices, EHRs

  July 10, 2018