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9,217 catalysts · 3,086 8k filing · 2,029 grant · 1,000 device adverse event · 897 approval · 659 device 510k · 583 earnings
9,217 catalysts · 3,086 8k filing · 2,029 grant · 1,000 device adverse event · 897 approval · 659 device 510k · 583 earnings
Centricity Universal Viewer Software Versions 6.0 through 6.0 Sp10.4.1, a device that displays medical images (including mammograms) and data from various imaging sources, Model Numbers 2088026-406, 2100169-001, 2088026-985, 2088026-971, 2088026-614, 2088026-713, 2088026-994, 2100491-006, 2088026-723, 2088026-308, 2104867-044, 2100491-012, 2088026-962, 2088026-969, 2102676-001, 2088026-936, 2088026-960, K1220JWED, 2088026-806, 2088026-506, 2088026-026, 2088026-970, 2088026-943, 2088026-990, 2088026-940, 2088026-959, 2088026-967, 2088026-989, 2104867-045, 2088026-993, 2088026-306, 2102675-010, 2088026-948, 2088026-957, 2088026-973, 2088026-946, 2088026-715, 2088026-906 — Reason: There is a potential cybersecurity vulnerability affecting certain versions of Centricity Universal Viewer. User login credentials may be exposed on the local client workstation, which could allow an unauthorized individual to potentially impact system availability and/or manipulate data. — Status: Ongoing
MiniMed" 780G - MMT-1884 MiniMed" 780G - MMT-1886 With Software 6.60 and 6.61 — Reason: Three software defects (Pump Error 53, BG check, and Critical Pump Error (Open Book Image)) that occurred as a result of software updates (versions 6.60, 6.61, and 6.62), which could result in a risk of hypoglycemia or hyperglycemia due to inaccuracies in insulin delivery (either under-delivery, over-delivery, or cessation of delivery). — Status: Ongoing
Tandem pumps are battery-operated infusion pumps capable of both basal and bolus delivery of insulin. The pumps utilize a motor-driven mechanism to deliver insulin from within a disposable cartridge, through an infusion set, into a patient s subcutaneous tissue. As with current insulin infusion pumps on the U.S. market, the desired timing and quantity of the insulin delivery is programmed by the user (i.e., the patient). — Reason: The Czech language user guide contained multiple translation errors. The most significant error was that it incorrectly instructs users to verify that the infusion set is connected to the body, when it should instead direct users to confirm that the infusion set is not connected to the body. Following this instruction could result in unintended insulin delivery, potentially leading to a hypoglycemic event. — Status: Ongoing
Centricity Universal Viewer Software Versions 5.0 SP6 through UV 5.0 SP7.1, a device that displays medical images (including mammograms) and data from various imaging sources, Model Numbers 2088026-026, 2088026-115, 2088026-043, K2042VJED, 2088026-132, 2088026-003, 2088026-110, 2089629-003, 2066908-136, 2066908-150 — Reason: There is a potential cybersecurity vulnerability affecting certain versions of Centricity Universal Viewer. User login credentials may be exposed on the local client workstation, which could allow an unauthorized individual to potentially impact system availability and/or manipulate data. — Status: Ongoing
HealthCast "Vital Sync" Remote Patient Monitoring System which consists of: Product Number: VSLBASE03P / VITALSYNCSW03 Model / UDI-DI codes: Vital Sync 3.3.1 / 10884521844933 Vital Sync 3.4.0 / 10884521844940 Vital Sync 3.4.1 / 10884521847569 (OUS Only) Vital Sync 3.4.2 / 10884521856127 Product Number: VSLBASE04P / VITALSYNCSW04 Model / UDI-DI codes: Vital Sync 4.0.0 / 10884521849358 Vital Sync 4.0.2 / 10884521856134 The Vital Sync" Informatics Manager is software that is intended to route and store medical device data and device diagnostic information from supported devices to the Virtual Patient Monitoring Platform, 3rd Party Annunciation Systems, Electronic Medical Record (EMR) and Clinical Information System (CIS). — Reason: Due to complaints and investigations stating that alarms from the primary patient bedside monitor was not alarming/being transmitted and received on the remote patient monitoring system. — Status: Ongoing
Centricity Universal Viewer Software Versions 7.0 through 7.0 Sp2.0.1, a device that displays medical images (including mammograms) and data from various imaging sources, Model Numbers 5826659-027, 5826659-029, 5826659-032, 5826659-033, 5826659-028, 5826659-034, 5826659-030, 5826659-019, 5826659-022, 5826659-026, 5826659-023, 5826659-031, 5826659-025, 5826659-002, 5826659-021, 5826659-037, 5826659-014, 5826659-016, 5826659-013 — Reason: There is a potential cybersecurity vulnerability affecting certain versions of Centricity Universal Viewer. User login credentials may be exposed on the local client workstation, which could allow an unauthorized individual to potentially impact system availability and/or manipulate data. — Status: Ongoing
EB grant. $7,140. PI: Stacy Marla Copp
AG grant. $46,086. PI: Anna Saylor
NR grant. $1,422,387. PI: EILEEN T LAKE
Product code: DQX. Advisory committee: Cardiovascular. Type: Special
AA grant. $78,520. PI: Meredith Rose Bauer
AG grant. $401,404. PI: Rugang Zhang
CA grant. $766,371. PI: Ting-Yuan Cheng
NS grant. $242,250. PI: Ukpong Bassey Eyo
AG grant. $700,795. PI: VISHWA DEEP DIXIT
NS grant. $136,620. PI: Rose Berthe Creed
AG grant. $441,460. PI: Fan Fan
DK grant. $832,783. PI: Todd Christopher Bradley
GM grant. $243,046. PI: Eric James Horstick
AG grant. $49,538. PI: Allegra Kawles
GM grant. $264,270. PI: Ryan L Hanson
CA grant. $267,208. PI: Ren Xu
AI grant. $482,625. PI: Jonah B. Sacha
AG grant. $666,504. PI: Christopher Fry
AI grant. $423,500. PI: Maria Bettini
AG grant. $19,600. PI: TERRY L. SHEPPARD
TW grant. $185,185. PI: JOSEPH W HOGAN
AI grant. $51,600. PI: Barry Ryan Lutz
CA grant. $352,275. PI: Minna Roh
AI grant. $80,224. PI: Anastacia R Parks
HD grant. $151,482. PI: Lila A Sheira
AG grant. $618,410. PI: Danapala M. M. Janaka Senarathna
AR grant. $15,000. PI: Stephanie Kliethermes
NS grant. $511,402. PI: Cenk Ayata
AG grant. $552,154. PI: Jason Wright
NS grant. $247,995. PI: Nicolas Julian Abreu
DK grant. $193,075. PI: Angelina Dixon
AI grant. $739,353. PI: Murali Prakriya
AG grant. $689,148. PI: KENNETH WALSH
AG grant. $127,710. PI: Aleda Leis
AI grant. $51,676. PI: Russell Ryan Kempker
NR grant. $46,559. PI: Katherine Erin Kruger
AG grant. $589,614. PI: Andrew ASCHENBRENNER
HD grant. $44,280. PI: Sinclair William Emans
VA grant. PI: Phoebe Tsao
HL grant. $54,538. PI: Stephanie Danni Song
DK grant. $709,369. PI: Ciro Maurizio Amato
AG grant. $680,818. PI: Andrew Patrick Ambrosy
DC grant. $618,089. PI: Rita R Patel
DK grant. $757,885. PI: Sanjeev Kumar